LIRA-PRIME: Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes
Study Details
Study Description
Brief Summary
This trial is conducted globally. The aim of the trial is to investigate efficacy in controlling glycaemia with Victoza® (liraglutide) as add-on to metformin background treatment vs. OADs as add-on to metformin background treatment for 104 weeks of treatment in subjects with type 2 diabetes.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Liraglutide 1.8 mg Add-on to metformin |
Drug: liraglutide
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
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Active Comparator: OAD Add-on to metformin. Treatment with one OAD selected at the discretion of the investigator. Subjects randomised to the OAD arm must remain on the same OAD throughout the trial. |
Drug: alpha-glucosidase inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
Drug: DPP-4 inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
Drug: meglitinides
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
Drug: SGLT-2 inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
Drug: sulphonylurea
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
Drug: thiazolidinediones
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
|
Outcome Measures
Primary Outcome Measures
- Time to Inadequate Glycaemic Control [Weeks 26-104]
Inadequate glycaemic control was defined as glycosylated haemoglobin (HbA1c) of 7.0% (53 mmol/mol) or greater at two consecutive visits after the first 26 weeks of treatment and up to 104 weeks. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function. HbA1c was recorded at weeks 38, 52, 65, 78, 91 and 104.
Secondary Outcome Measures
- Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control) [Weeks 0-104]
The time to premature treatment discontinuation (for any reason including inadequate glycaemic control) was analysed and presented using the generalised log rank test. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function.
- Change in HbA1c [Week 0, week 104/premature treatment discontinuation]
Change from baseline (week 0) in HbA1c at week 104 or at premature treatment discontinuation is presented.
- Participants Who Achieve HbA1c ≤6.5% (Yes/No) [Week 104/Premature treatment discontinuation]
Participants who achieved HbA1c ≤6.5% (yes/no) is presented.
- Participants Who Achieve HbA1c ≤7.0% Without Weight Gain [Week 104/Premature treatment discontinuation]
Participants who achieved HbA1c ≤7.0% without weight gain (yes/no) is presented.
- Participants Who Achieve HbA1c ≤7.0% Without Treatment Emergent Severe Hypoglycaemic Episodes or BG Confirmed Symptomatic Hypoglycaemic Episodes [Week 104/Premature treatment discontinuation]
Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 millimoles per liter (mmol/L) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than the day after the last day on trial product. Participants who achieved HbA1c ≤7.0% without treatment emergent severe hypoglycaemic episodes or BG confirmed symptomatic hypoglycaemic episodes (yes/no) is presented.
- Participants Who Achieve HbA1c ≤7.0% Without Weight Gain and no Treatment Emergent Severe Hypoglycaemic Episodes or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes [Week 104/Premature treatment discontinuation]
Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than the day after the last day on trial product. Participants who achieved HbA1c ≤7.0% without weight gain and no treatment emergent severe hypoglycaemic episodes or BG confirmed symptomatic hypoglycaemic episodes (yes/no) is presented.
- Change in Fasting Plasma Glucose (FPG) [Week 0, week 104/premature treatment discontinuation]
Change from baseline (week 0) in FPG at week 104 or at premature treatment discontinuation is presented.
- Change in Body Weight [Week 0, week 104/premature treatment discontinuation]
Change from baseline (week 0) in body weight at week 104 or at premature treatment discontinuation is presented.
- Change in Body Mass Index (BMI) [Week 0, week 104/premature treatment discontinuation]
Change from baseline (week 0) in BMI at week 104 or at premature treatment discontinuation is presented.
- Change in Blood Pressure (Systolic and Diastolic Blood Pressure) [Week 0, week 104/premature treatment discontinuation]
Change from baseline (week 0) in systolic and diastolic blood pressure at week 104 or at premature treatment discontinuation is presented.
- Number of Severe Hypoglycaemic Episodes [Weeks 0-104]
Severe hypoglycaemic episodes were defined as episodes that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Number of severe hypoglycaemic episodes that occured during weeks 0-104 are presented.
- Number of Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes [Weeks 0-104]
Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Number of severe or BG confirmed symptomatic hypoglycaemic episodes that occured during weeks 0-104 are presented.
- Number of Documented Symptomatic Hypoglycaemic Episodes (ADA) [Weeks 0-104]
Documented symptomatic hypoglycaemic were defined as episodes with typical symptoms of hypoglycaemia accompanied by measure plasma glucose concentration <= 3.9 mmol/L. Number of documented symptomatic hypoglycaemic episodes that occured during the weeks 0-104 are presented.
- Number of Serious Adverse Events (SAEs) [Weeks 0-105]
A serious adverse event (SAE) was defined as any event that resulted in any of the following: death, life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect or suspicion of transmission of infectious agents via the trial product. An SAE was considered as treatment emergent if it had an onset or increase in severity on or after the time of first trial product administration and no later than 7 days after the time of last trial product administration. Number of treatment emergent serious adverse events are presented.
- Number of AEs Leading to Permanent Discontinuation of Trial Product [Weeks 0-105]
An adverse event (AE) was any untoward medical occurrence in a participant who administered a product, and which did not necessarily had a causal relationship with this treatment. An AE was considered as treatment emergent if it had an onset or increase in severity on or after the time of first trial product administration and no later than 7 days after the time of last trial product administration. Number of treatment emergent AEs that led to permanent discontinuation of trial product are presented.
- Change in Lipids: HDL Cholesterol, LDL-cholesterol, Total Cholesterol, Triglycerides [Week 0, week 104/premature treatment discontinuation]
Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total cholesterol (TC) and triglycerides (TG) at week 104 or at premature treatment discontinuation is presented.
- Change in Biochemistry- Alanine Aminotransferase (ALAT), Amylase, Aspartate Aminotransferase (ASAT), Lipase [Week 0, week 104/premature treatment discontinuation]
Change from baseline (week 0) in alanine aminotransferase (ALAT), amylase, aspartate aminotransferase (ASAT) and lipase at week 104 or at premature treatment discontinuation is presented.
- Change in Biochemistry- Creatinine, Total Bilirubin [Week 0, week 104/premature treatment discontinuation]
Change from baseline (week 0) in creatinine and total bilirubin (TB) at week 104 or at premature treatment discontinuation is presented.
- Change in Biochemistry- Estimated Glomerular Filtration Rate (eGFR) Serum [Week 0, week 104/premature treatment discontinuation]
The estimated GFR was derived from serum creatinine using the MDRD (Modification of diet in renal disease) formula. eGFR was measured as milliliter per min per specific surface area (mL/min/SSA).
- Change in Potassium [Week 0, week 104/premature treatment discontinuation]
Change from baseline (week 0) in potassium at week 104 or at premature treatment discontinuation is presented.
- Change in Haemoglobin [Week 0, week 104/premature treatment discontinuation]
Change from baseline (week 0) in haemoglobin at week 104 or at premature treatment discontinuation is presented.
- Change in Pulse [Week 0, week 104/premature treatment discontinuation]
Change from baseline (week 0) in pulse at week 104 or at premature treatment discontinuation is presented.
Eligibility Criteria
Criteria
Inclusion Criteria: - Male or female at least 18 years of age at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes equal to or above 90 days prior to the screening visit - Stable daily dose of metformin as monotherapy equal to or above 1500 mg or maximum tolerated dose within 60 days prior to the screening visit - HbA1c 7.5-9.0% (59-75 mmol/mol) (both inclusive) and measured within the last 90 days prior to the screening visit Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) - Treatment with any medication for the indication of diabetes other than metformin in a period of 60 days before the screening visit. An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with intercurrent illness - Receipt of any investigational medicinal product within 30 days before the screening visit - Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
Contacts and Locations
Locations
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1 | Novo Nordisk Investigational Site | Birmingham | Alabama | United States | 35211 |
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135 | Novo Nordisk Investigational Site | Indian Land | South Carolina | United States | 29707 |
136 | Novo Nordisk Investigational Site | Pelzer | South Carolina | United States | 29669 |
137 | Novo Nordisk Investigational Site | Simpsonville | South Carolina | United States | 29681 |
138 | Novo Nordisk Investigational Site | Rapid City | South Dakota | United States | 57702 |
139 | Novo Nordisk Investigational Site | Athens | Tennessee | United States | 37303 |
140 | Novo Nordisk Investigational Site | Chattanooga | Tennessee | United States | 37404 |
141 | Novo Nordisk Investigational Site | Humboldt | Tennessee | United States | 38343 |
142 | Novo Nordisk Investigational Site | Kingsport | Tennessee | United States | 37660 |
143 | Novo Nordisk Investigational Site | Tullahoma | Tennessee | United States | 37388 |
144 | Novo Nordisk Investigational Site | Arlington | Texas | United States | 76014-2010 |
145 | Novo Nordisk Investigational Site | Arlington | Texas | United States | 76015 |
146 | Novo Nordisk Investigational Site | Carrollton | Texas | United States | 75010 |
147 | Novo Nordisk Investigational Site | Corpus Christi | Texas | United States | 78404 |
148 | Novo Nordisk Investigational Site | Corpus Christi | Texas | United States | 78413 |
149 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75251 |
150 | Novo Nordisk Investigational Site | Fort Worth | Texas | United States | 76164 |
151 | Novo Nordisk Investigational Site | Georgetown | Texas | United States | 78626 |
152 | Novo Nordisk Investigational Site | Gonzales | Texas | United States | 78629 |
153 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77024 |
154 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77025-1669 |
155 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77061 |
156 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77074 |
157 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77079 |
158 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77081 |
159 | Novo Nordisk Investigational Site | Irving | Texas | United States | 75061-2210 |
160 | Novo Nordisk Investigational Site | Kerrville | Texas | United States | 78028 |
161 | Novo Nordisk Investigational Site | Killeen | Texas | United States | 76543 |
162 | Novo Nordisk Investigational Site | Longview | Texas | United States | 75605 |
163 | Novo Nordisk Investigational Site | Missouri City | Texas | United States | 77459 |
164 | Novo Nordisk Investigational Site | New Braunfels | Texas | United States | 78130 |
165 | Novo Nordisk Investigational Site | San Antonio | Texas | United States | 78240 |
166 | Novo Nordisk Investigational Site | Splendora | Texas | United States | 77372 |
167 | Novo Nordisk Investigational Site | Sugar Land | Texas | United States | 77478 |
168 | Novo Nordisk Investigational Site | Sugar Land | Texas | United States | 77479 |
169 | Novo Nordisk Investigational Site | Waco | Texas | United States | 76710 |
170 | Novo Nordisk Investigational Site | Bountiful | Utah | United States | 84010 |
171 | Novo Nordisk Investigational Site | Saint George | Utah | United States | 84790 |
172 | Novo Nordisk Investigational Site | Danville | Virginia | United States | 24541 |
173 | Novo Nordisk Investigational Site | Gloucester Courthouse | Virginia | United States | 23061 |
174 | Novo Nordisk Investigational Site | Norfolk | Virginia | United States | 23510-2015 |
175 | Novo Nordisk Investigational Site | Richmond | Virginia | United States | 23219 |
176 | Novo Nordisk Investigational Site | Virginia Beach | Virginia | United States | 23454 |
177 | Novo Nordisk Investigational Site | Bellevue | Washington | United States | 98004-4604 |
178 | Novo Nordisk Investigational Site | Spokane | Washington | United States | 99216-1557 |
179 | Novo Nordisk Investigational Site | Walla Walla | Washington | United States | 99362-4445 |
180 | Novo Nordisk Investigational Site | Surrey | British Columbia | Canada | V3Z 2N6 |
181 | Novo Nordisk Investigational Site | Mount Pearl | Newfoundland and Labrador | Canada | A1N 1W7 |
182 | Novo Nordisk Investigational Site | Truro | Nova Scotia | Canada | B2N 1L2 |
183 | Novo Nordisk Investigational Site | Hamilton | Ontario | Canada | L8M 1K7 |
184 | Novo Nordisk Investigational Site | Sarnia | Ontario | Canada | N7T 4X3 |
185 | Novo Nordisk Investigational Site | Strathroy | Ontario | Canada | N7G 1Y7 |
186 | Novo Nordisk Investigational Site | Toronto | Ontario | Canada | M3J 1N2 |
187 | Novo Nordisk Investigational Site | Toronto | Ontario | Canada | M9V 4B4 |
188 | Novo Nordisk Investigational Site | Waterloo | Ontario | Canada | N2J 1C4 |
189 | Novo Nordisk Investigational Site | Montreal | Quebec | Canada | H4N 2W2 |
190 | Novo Nordisk Investigational Site | St-Marc-des-Carrières | Quebec | Canada | G0A 4B0 |
191 | Novo Nordisk Investigational Site | Quebec | Canada | G1G 3Y8 | |
192 | Novo Nordisk Investigational Site | Bogota | Colombia | 110221 | |
193 | Novo Nordisk Investigational Site | Bogota | Colombia | 111211 | |
194 | Novo Nordisk Investigational Site | Medellin | Colombia | ||
195 | Novo Nordisk Investigational Site | Bangalore | Karnataka | India | 560 017 |
196 | Novo Nordisk Investigational Site | Bangalore | Karnataka | India | 560002 |
197 | Novo Nordisk Investigational Site | Bangalore | Karnataka | India | 560054 |
198 | Novo Nordisk Investigational Site | Mysore | Karnataka | India | 570001 |
199 | Novo Nordisk Investigational Site | Indore | Madhya Pradesh | India | 452008 |
200 | Novo Nordisk Investigational Site | Nagpur | Maharashtra | India | 440003 |
201 | Novo Nordisk Investigational Site | Pune | Maharashtra | India | 411001 |
202 | Novo Nordisk Investigational Site | Pune | Maharashtra | India | 411004 |
203 | Novo Nordisk Investigational Site | Pune | Maharashtra | India | 411013 |
204 | Novo Nordisk Investigational Site | Hyderabad | Telengana | India | 500033 |
205 | Novo Nordisk Investigational Site | Lucknow | Uttar Pradesh | India | 226005 |
206 | Novo Nordisk Investigational Site | Noida | Uttar Pradesh | India | 201301 |
207 | Novo Nordisk Investigational Site | Kolkata | West Bengal | India | 700027 |
208 | Novo Nordisk Investigational Site | Kolkata | West Bengal | India | 700054 |
209 | Novo Nordisk Investigational Site | Hubli | India | 580022 | |
210 | Novo Nordisk Investigational Site | Ludhiana | India | 141001 | |
211 | Novo Nordisk Investigational Site | Riga | Latvia | LV1011 | |
212 | Novo Nordisk Investigational Site | Riga | Latvia | LV1057 | |
213 | Novo Nordisk Investigational Site | Tukums | Latvia | LV3101 | |
214 | Novo Nordisk Investigational Site | Achrafieh | Lebanon | ||
215 | Novo Nordisk Investigational Site | Beirut | Lebanon | ||
216 | Novo Nordisk Investigational Site | Hazmieh | Lebanon | ||
217 | Novo Nordisk Investigational Site | Jbeil | Lebanon | ||
218 | Novo Nordisk Investigational Site | Toa Baja | Puerto Rico | 00949 | |
219 | Novo Nordisk Investigational Site | Trujillo Alto | Puerto Rico | 00976 | |
220 | Novo Nordisk Investigational Site | Dzerzhinskiy | Russian Federation | 140091 | |
221 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 101990 | |
222 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 121293 | |
223 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 125315 | |
224 | Novo Nordisk Investigational Site | Saint-Petersburg | Russian Federation | 197762 | |
225 | Novo Nordisk Investigational Site | Belgrade | Serbia | 11000 | |
226 | Novo Nordisk Investigational Site | Kragujevac | Serbia | 34000 | |
227 | Novo Nordisk Investigational Site | Nis | Serbia | 18000 | |
228 | Novo Nordisk Investigational Site | Novi Sad | Serbia | 21000 | |
229 | Novo Nordisk Investigational Site | Adapazari | Turkey | 54290 | |
230 | Novo Nordisk Investigational Site | Istanbul | Turkey | 34130 | |
231 | Novo Nordisk Investigational Site | Istanbul | Turkey | 34722 | |
232 | Novo Nordisk Investigational Site | Istanbul | Turkey | 34890 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
- NN2211-4232
- 2015-002417-29
- U1111-1170-7035
Study Results
Participant Flow
Recruitment Details | The trial was conducted at 219 sites in Canada (11), Colombia (3), India (16), Latvia (2), Lebanon (4), Russian Federation (5), Serbia (6), Turkey (4) and the United States (168). |
---|---|
Pre-assignment Detail | Participants were randomised in a 1:1 manner to receive either liraglutide or an oral antidiabetic drug (OAD) both as add-on to background therapy with metformin. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Period Title: Overall Study | ||
STARTED | 996 | 995 |
Treated | 980 | 984 |
Full Analysis Set (FAS) | 996 | 995 |
Safety Analysis Set (SAS) | 980 | 984 |
COMPLETED | 446 | 362 |
NOT COMPLETED | 550 | 633 |
Baseline Characteristics
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug | Total |
---|---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. | Total of all reporting groups |
Overall Participants | 996 | 995 | 1991 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
57.6
(11.0)
|
57.1
(10.7)
|
57.4
(10.8)
|
Sex: Female, Male (Count of Participants) | |||
Female |
476
47.8%
|
471
47.3%
|
947
47.6%
|
Male |
520
52.2%
|
524
52.7%
|
1044
52.4%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
176
17.7%
|
189
19%
|
365
18.3%
|
Not Hispanic or Latino |
820
82.3%
|
806
81%
|
1626
81.7%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race/Ethnicity, Customized (Count of Participants) | |||
American Indian or Alaska Native |
3
0.3%
|
6
0.6%
|
9
0.5%
|
Asian |
149
15%
|
141
14.2%
|
290
14.6%
|
Black or African American |
101
10.1%
|
106
10.7%
|
207
10.4%
|
Native Hawaiian or Other Pacific Islander |
3
0.3%
|
2
0.2%
|
5
0.3%
|
White |
724
72.7%
|
714
71.8%
|
1438
72.2%
|
Other |
16
1.6%
|
26
2.6%
|
42
2.1%
|
Outcome Measures
Title | Time to Inadequate Glycaemic Control |
---|---|
Description | Inadequate glycaemic control was defined as glycosylated haemoglobin (HbA1c) of 7.0% (53 mmol/mol) or greater at two consecutive visits after the first 26 weeks of treatment and up to 104 weeks. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function. HbA1c was recorded at weeks 38, 52, 65, 78, 91 and 104. |
Time Frame | Weeks 26-104 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. Overall number of participants analyzed=participants with available data. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 416 | 547 |
Median (Inter-Quartile Range) [Weeks] |
108.9
|
64.9
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Liraglutide 1.8 mg, Oral Antidiabetic Drug |
---|---|---|
Comments | Test for no treatment difference is based on using a generalised log-rank test for interval censored failure time data. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <.0001 |
Comments | ||
Method | Log Rank | |
Comments |
Title | Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control) |
---|---|
Description | The time to premature treatment discontinuation (for any reason including inadequate glycaemic control) was analysed and presented using the generalised log rank test. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function. |
Time Frame | Weeks 0-104 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. Overall number of participants analyzed=participants with available data. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 532 | 624 |
Median (Inter-Quartile Range) [Weeks] |
80.4
|
52.3
|
Title | Change in HbA1c |
---|---|
Description | Change from baseline (week 0) in HbA1c at week 104 or at premature treatment discontinuation is presented. |
Time Frame | Week 0, week 104/premature treatment discontinuation |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 996 | 995 |
Change at week 104 |
-1.4
(1.06)
|
-1.1
(1.04)
|
Change at premature treatment discontinuation |
-0.6
(1.03)
|
-0.2
(1.56)
|
Title | Participants Who Achieve HbA1c ≤6.5% (Yes/No) |
---|---|
Description | Participants who achieved HbA1c ≤6.5% (yes/no) is presented. |
Time Frame | Week 104/Premature treatment discontinuation |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 996 | 995 |
Yes |
255
25.6%
|
162
16.3%
|
No |
741
74.4%
|
833
83.7%
|
Title | Participants Who Achieve HbA1c ≤7.0% Without Weight Gain |
---|---|
Description | Participants who achieved HbA1c ≤7.0% without weight gain (yes/no) is presented. |
Time Frame | Week 104/Premature treatment discontinuation |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 996 | 995 |
Yes |
329
33%
|
234
23.5%
|
No |
667
67%
|
761
76.5%
|
Title | Participants Who Achieve HbA1c ≤7.0% Without Treatment Emergent Severe Hypoglycaemic Episodes or BG Confirmed Symptomatic Hypoglycaemic Episodes |
---|---|
Description | Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 millimoles per liter (mmol/L) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than the day after the last day on trial product. Participants who achieved HbA1c ≤7.0% without treatment emergent severe hypoglycaemic episodes or BG confirmed symptomatic hypoglycaemic episodes (yes/no) is presented. |
Time Frame | Week 104/Premature treatment discontinuation |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 996 | 995 |
Yes |
388
39%
|
292
29.3%
|
No |
608
61%
|
703
70.7%
|
Title | Participants Who Achieve HbA1c ≤7.0% Without Weight Gain and no Treatment Emergent Severe Hypoglycaemic Episodes or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes |
---|---|
Description | Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than the day after the last day on trial product. Participants who achieved HbA1c ≤7.0% without weight gain and no treatment emergent severe hypoglycaemic episodes or BG confirmed symptomatic hypoglycaemic episodes (yes/no) is presented. |
Time Frame | Week 104/Premature treatment discontinuation |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 996 | 995 |
Yes |
320
32.1%
|
227
22.8%
|
No |
676
67.9%
|
768
77.2%
|
Title | Change in Fasting Plasma Glucose (FPG) |
---|---|
Description | Change from baseline (week 0) in FPG at week 104 or at premature treatment discontinuation is presented. |
Time Frame | Week 0, week 104/premature treatment discontinuation |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 996 | 995 |
Change at week 104 |
-2.2
(2.65)
|
-1.2
(2.46)
|
Change at premature treatment discontinuation |
-0.6
(2.91)
|
-0.6
(3.76)
|
Title | Change in Body Weight |
---|---|
Description | Change from baseline (week 0) in body weight at week 104 or at premature treatment discontinuation is presented. |
Time Frame | Week 0, week 104/premature treatment discontinuation |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 996 | 995 |
Change at week 104 |
-3.8
(6.38)
|
-3.5
(6.19)
|
Change at premature treatment discontinuation |
-2.9
(3.74)
|
-2.2
(4.93)
|
Title | Change in Body Mass Index (BMI) |
---|---|
Description | Change from baseline (week 0) in BMI at week 104 or at premature treatment discontinuation is presented. |
Time Frame | Week 0, week 104/premature treatment discontinuation |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 996 | 995 |
Change at week 104 |
-1.3
(2.26)
|
-1.2
(2.14)
|
Change at premature treatment discontinuation |
-1.1
(1.33)
|
-0.8
(1.71)
|
Title | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) |
---|---|
Description | Change from baseline (week 0) in systolic and diastolic blood pressure at week 104 or at premature treatment discontinuation is presented. |
Time Frame | Week 0, week 104/premature treatment discontinuation |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 996 | 995 |
SBP: Change at week 104 |
-2.4
(15.09)
|
-1.1
(15.11)
|
SBP: Change at premature treatment discontinuation |
-2.8
(15.99)
|
-2.9
(15.23)
|
DBP: Change at week 104 |
-1.3
(9.51)
|
-0.6
(9.54)
|
DBP: Change at premature treatment discontinuation |
-1.0
(11.27)
|
0.2
(9.69)
|
Title | Number of Severe Hypoglycaemic Episodes |
---|---|
Description | Severe hypoglycaemic episodes were defined as episodes that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Number of severe hypoglycaemic episodes that occured during weeks 0-104 are presented. |
Time Frame | Weeks 0-104 |
Outcome Measure Data
Analysis Population Description |
---|
Safety analysis set (SAS) included all participants exposed to at least one dose of trial product. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 980 | 984 |
Number [Episodes] |
32
|
52
|
Title | Number of Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes |
---|---|
Description | Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Number of severe or BG confirmed symptomatic hypoglycaemic episodes that occured during weeks 0-104 are presented. |
Time Frame | Weeks 0-104 |
Outcome Measure Data
Analysis Population Description |
---|
SAS included all participants exposed to at least one dose of trial product. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 980 | 984 |
Number [Episodes] |
24
|
44
|
Title | Number of Documented Symptomatic Hypoglycaemic Episodes (ADA) |
---|---|
Description | Documented symptomatic hypoglycaemic were defined as episodes with typical symptoms of hypoglycaemia accompanied by measure plasma glucose concentration <= 3.9 mmol/L. Number of documented symptomatic hypoglycaemic episodes that occured during the weeks 0-104 are presented. |
Time Frame | Weeks 0-104 |
Outcome Measure Data
Analysis Population Description |
---|
SAS included all participants exposed to at least one dose of trial product. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 980 | 984 |
Number [Episodes] |
98
|
155
|
Title | Number of Serious Adverse Events (SAEs) |
---|---|
Description | A serious adverse event (SAE) was defined as any event that resulted in any of the following: death, life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect or suspicion of transmission of infectious agents via the trial product. An SAE was considered as treatment emergent if it had an onset or increase in severity on or after the time of first trial product administration and no later than 7 days after the time of last trial product administration. Number of treatment emergent serious adverse events are presented. |
Time Frame | Weeks 0-105 |
Outcome Measure Data
Analysis Population Description |
---|
SAS included all participants exposed to at least one dose of trial product. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 980 | 984 |
Number [Events] |
145
|
140
|
Title | Number of AEs Leading to Permanent Discontinuation of Trial Product |
---|---|
Description | An adverse event (AE) was any untoward medical occurrence in a participant who administered a product, and which did not necessarily had a causal relationship with this treatment. An AE was considered as treatment emergent if it had an onset or increase in severity on or after the time of first trial product administration and no later than 7 days after the time of last trial product administration. Number of treatment emergent AEs that led to permanent discontinuation of trial product are presented. |
Time Frame | Weeks 0-105 |
Outcome Measure Data
Analysis Population Description |
---|
SAS included all participants exposed to at least one dose of trial product. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 980 | 984 |
Number [Events] |
188
|
98
|
Title | Change in Lipids: HDL Cholesterol, LDL-cholesterol, Total Cholesterol, Triglycerides |
---|---|
Description | Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total cholesterol (TC) and triglycerides (TG) at week 104 or at premature treatment discontinuation is presented. |
Time Frame | Week 0, week 104/premature treatment discontinuation |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 980 | 984 |
HDL: Change at week 104 |
0.1
(0.20)
|
0.1
(0.19)
|
HDL: Change at premature treatment discontinuation |
-0.0
(0.17)
|
0.0
(0.20)
|
LDL: Change at week 104 |
-0.1
(0.80)
|
0.0
(0.83)
|
LDL: Change at premature treatment discontinuation |
-0.1
(0.68)
|
-0.1
(0.85)
|
TC: Change at week 104 |
-0.2
(0.92)
|
0.1
(0.99)
|
TC: Change at premature treatment discontinuation |
-0.0
(0.81)
|
-0.1
(0.96)
|
TG: Change at week 104 |
-0.3
(0.95)
|
-0.1
(1.25)
|
TG: Change at premature treatment discontinuation |
-0.0
(1.13)
|
-0.0
(1.30)
|
Title | Change in Biochemistry- Alanine Aminotransferase (ALAT), Amylase, Aspartate Aminotransferase (ASAT), Lipase |
---|---|
Description | Change from baseline (week 0) in alanine aminotransferase (ALAT), amylase, aspartate aminotransferase (ASAT) and lipase at week 104 or at premature treatment discontinuation is presented. |
Time Frame | Week 0, week 104/premature treatment discontinuation |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 980 | 984 |
ALAT: Week 104 |
-4.6
(17.83)
|
-5.4
(17.13)
|
ALAT: Premature treatment discontinuation |
-3.2
(12.44)
|
-3.3
(14.67)
|
Amylase: Week 104 |
8.9
(30.93)
|
5.1
(26.30)
|
Amylase: Premature treatment discontinuation |
0.6
(23.61)
|
2.1
(17.92)
|
ASAT: Week 104 |
-2.0
(13.27)
|
-2.3
(11.85)
|
ASAT: Premature treatment discontinuation |
-1.9
(10.76)
|
-0.4
(11.64)
|
Lipase: Week 104 |
15.1
(67.69)
|
-0.5
(50.03)
|
Lipase: Premature treatment discontinuation |
10.4
(32.40)
|
-2.2
(35.79)
|
Title | Change in Biochemistry- Creatinine, Total Bilirubin |
---|---|
Description | Change from baseline (week 0) in creatinine and total bilirubin (TB) at week 104 or at premature treatment discontinuation is presented. |
Time Frame | Week 0, week 104/premature treatment discontinuation |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 980 | 984 |
Creatinine: week 104 |
3.3
(13.37)
|
1.0
(12.86)
|
Creatinine: premature treatment discontinuation |
2.9
(12.06)
|
2.6
(21.13)
|
TB: week 104 |
0.4
(4.47)
|
0.7
(3.80)
|
TB: premature treatment discontinuation |
-0.0
(2.78)
|
-0.6
(3.17)
|
Title | Change in Biochemistry- Estimated Glomerular Filtration Rate (eGFR) Serum |
---|---|
Description | The estimated GFR was derived from serum creatinine using the MDRD (Modification of diet in renal disease) formula. eGFR was measured as milliliter per min per specific surface area (mL/min/SSA). |
Time Frame | Week 0, week 104/premature treatment discontinuation |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 980 | 984 |
Change at week 104 |
-5.1
(20.33)
|
-1.6
(16.29)
|
Change at premature treatment discontinuation |
-3.0
(12.56)
|
-1.7
(15.01)
|
Title | Change in Potassium |
---|---|
Description | Change from baseline (week 0) in potassium at week 104 or at premature treatment discontinuation is presented. |
Time Frame | Week 0, week 104/premature treatment discontinuation |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 980 | 984 |
Change at week 104 |
-0.1
(0.60)
|
-0.0
(0.59)
|
Change at premature treatment discontinuation |
-0.0
(0.44)
|
-0.2
(0.71)
|
Title | Change in Haemoglobin |
---|---|
Description | Change from baseline (week 0) in haemoglobin at week 104 or at premature treatment discontinuation is presented. |
Time Frame | Week 0, week 104/premature treatment discontinuation |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 980 | 984 |
Change at week 104 |
-0.4
(1.07)
|
-0.0
(1.16)
|
Change at premature treatment discontinuation |
-0.3
(0.87)
|
-0.3
(1.12)
|
Title | Change in Pulse |
---|---|
Description | Change from baseline (week 0) in pulse at week 104 or at premature treatment discontinuation is presented. |
Time Frame | Week 0, week 104/premature treatment discontinuation |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. |
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug |
---|---|---|
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
Measure Participants | 980 | 984 |
Change at week 104 |
1.0
(10.25)
|
-0.6
(10.23)
|
Change at premature treatment discontinuation |
0.7
(9.84)
|
0.9
(10.59)
|
Adverse Events
Time Frame | Weeks 0-105 | |||
---|---|---|---|---|
Adverse Event Reporting Description | All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants exposed to at least one dose of trial product. | |||
Arm/Group Title | Liraglutide 1.8 mg | Oral Antidiabetic Drug | ||
Arm/Group Description | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. | ||
All Cause Mortality |
||||
Liraglutide 1.8 mg | Oral Antidiabetic Drug | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/980 (0.1%) | 8/984 (0.8%) | ||
Serious Adverse Events |
||||
Liraglutide 1.8 mg | Oral Antidiabetic Drug | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 92/980 (9.4%) | 81/984 (8.2%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 1/980 (0.1%) | 1 | 2/984 (0.2%) | 2 |
Blood loss anaemia | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Iron deficiency anaemia | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Leukocytosis | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Cardiac disorders | ||||
Acute myocardial infarction | 5/980 (0.5%) | 5 | 6/984 (0.6%) | 6 |
Angina pectoris | 4/980 (0.4%) | 4 | 1/984 (0.1%) | 1 |
Angina unstable | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Arrhythmia supraventricular | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Arteriosclerosis coronary artery | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Atrial fibrillation | 3/980 (0.3%) | 3 | 2/984 (0.2%) | 2 |
Atrioventricular block second degree | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Cardiac failure | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Cardiac failure congestive | 3/980 (0.3%) | 4 | 4/984 (0.4%) | 4 |
Cardiomyopathy | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Cardiovascular disorder | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Coronary artery disease | 1/980 (0.1%) | 1 | 2/984 (0.2%) | 2 |
Coronary artery stenosis | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Mitral valve incompetence | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Myocardial infarction | 0/980 (0%) | 0 | 2/984 (0.2%) | 2 |
Myocardial ischaemia | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Ventricular fibrillation | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Ear and labyrinth disorders | ||||
Vertigo positional | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Endocrine disorders | ||||
Empty sella syndrome | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Eye disorders | ||||
Cataract | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Exophthalmos | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Gastrointestinal disorders | ||||
Abdominal pain lower | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Chronic gastritis | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Colitis ischaemic | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Constipation | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Duodenal stenosis | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Enteritis | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Erosive duodenitis | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Gastric ulcer | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Gastrointestinal haemorrhage | 0/980 (0%) | 0 | 2/984 (0.2%) | 2 |
Gastrooesophageal reflux disease | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Hiatus hernia | 0/980 (0%) | 0 | 2/984 (0.2%) | 2 |
Impaired gastric emptying | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Oesophageal obstruction | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Oesophageal varices haemorrhage | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Oesophagitis | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Pancreatitis | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Pancreatitis acute | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Small intestinal obstruction | 1/980 (0.1%) | 2 | 0/984 (0%) | 0 |
Vomiting | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
General disorders | ||||
Asthenia | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Chest pain | 4/980 (0.4%) | 4 | 1/984 (0.1%) | 1 |
Incarcerated hernia | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Hepatobiliary disorders | ||||
Cholelithiasis | 0/980 (0%) | 0 | 2/984 (0.2%) | 2 |
Hepatic cirrhosis | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Hepatosplenomegaly | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Portal hypertension | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Infections and infestations | ||||
Bronchitis | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Diverticulitis | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Erysipelas | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Fournier's gangrene | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Gastroenteritis | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Gastroenteritis viral | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Influenza | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Lower respiratory tract infection | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Osteomyelitis | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Pneumonia | 4/980 (0.4%) | 4 | 5/984 (0.5%) | 5 |
Pneumonia influenzal | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Pneumonia streptococcal | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Postoperative wound infection | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Pulmonary sepsis | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Pyelonephritis acute | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Rectal abscess | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Scrotal abscess | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Sepsis | 0/980 (0%) | 0 | 3/984 (0.3%) | 3 |
Tonsillitis | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Urinary tract infection | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Urosepsis | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Injury, poisoning and procedural complications | ||||
Ankle fracture | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Arterial bypass occlusion | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Concussion | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Fall | 1/980 (0.1%) | 1 | 2/984 (0.2%) | 2 |
Femur fracture | 0/980 (0%) | 0 | 2/984 (0.2%) | 2 |
Gun shot wound | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Hip fracture | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Humerus fracture | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Joint dislocation | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Ligament rupture | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Lower limb fracture | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Lumbar vertebral fracture | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Rib fracture | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Road traffic accident | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Spinal compression fracture | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Wound | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Investigations | ||||
Troponin increased | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Metabolism and nutrition disorders | ||||
Dehydration | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Diabetic ketoacidosis | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Gout | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Hyperglycaemia | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Hyponatraemia | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Lactic acidosis | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Metabolic acidosis | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Obesity | 2/980 (0.2%) | 2 | 1/984 (0.1%) | 1 |
Musculoskeletal and connective tissue disorders | ||||
Back pain | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Intervertebral disc degeneration | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Intervertebral disc displacement | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Intervertebral disc protrusion | 2/980 (0.2%) | 2 | 0/984 (0%) | 0 |
Lumbar spinal stenosis | 2/980 (0.2%) | 2 | 0/984 (0%) | 0 |
Musculoskeletal chest pain | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Osteoarthritis | 3/980 (0.3%) | 3 | 1/984 (0.1%) | 1 |
Spinal stenosis | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Astrocytoma | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Bladder transitional cell carcinoma | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Breast cancer | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Colorectal cancer metastatic | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Gastrointestinal tract adenoma | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Invasive ductal breast carcinoma | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Lung adenocarcinoma | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Lung adenocarcinoma stage IV | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Lung cancer metastatic | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Lung neoplasm malignant | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Metastases to lung | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Ovarian adenoma | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Papillary thyroid cancer | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Pleural mesothelioma malignant | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Prostate cancer | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Rectal adenocarcinoma | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Rectosigmoid cancer stage III | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Triple negative breast cancer | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Nervous system disorders | ||||
Carotid artery stenosis | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Cerebral haemorrhage | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Cerebrovascular accident | 4/980 (0.4%) | 4 | 1/984 (0.1%) | 1 |
Dizziness | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Haemorrhagic stroke | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Headache | 2/980 (0.2%) | 2 | 0/984 (0%) | 0 |
Hypoaesthesia | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Hypoxic-ischaemic encephalopathy | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Lacunar infarction | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Lumbar radiculopathy | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Spinal cord haematoma | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Subarachnoid haemorrhage | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Syncope | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Transient ischaemic attack | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Pregnancy, puerperium and perinatal conditions | ||||
Ectopic pregnancy | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Psychiatric disorders | ||||
Anxiety | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Completed suicide | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Conversion disorder | 2/980 (0.2%) | 2 | 0/984 (0%) | 0 |
Delusion | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Delusional disorder, unspecified type | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Depression | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Panic attack | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Psychotic disorder | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Renal and urinary disorders | ||||
Acute kidney injury | 6/980 (0.6%) | 7 | 2/984 (0.2%) | 2 |
Calculus urinary | 2/980 (0.2%) | 2 | 0/984 (0%) | 0 |
Diabetic nephropathy | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
End stage renal disease | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Hydronephrosis | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Nephrolithiasis | 2/980 (0.2%) | 2 | 2/984 (0.2%) | 3 |
Renal colic | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Ureterolithiasis | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Reproductive system and breast disorders | ||||
Endometriosis | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Menorrhagia | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Ovarian cyst | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
Acute respiratory failure | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Asthma | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Chronic obstructive pulmonary disease | 1/980 (0.1%) | 1 | 1/984 (0.1%) | 1 |
Dyspnoea | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Interstitial lung disease | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Pneumothorax | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Pulmonary hypertension | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Respiratory distress | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Respiratory failure | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Surgical and medical procedures | ||||
Coronary artery bypass | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Gastrectomy | 0/980 (0%) | 0 | 1/984 (0.1%) | 1 |
Gastric bypass | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Metabolic surgery | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Spinal laminectomy | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Vascular disorders | ||||
Aortic aneurysm | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Arteriosclerosis | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Deep vein thrombosis | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Hypertension | 1/980 (0.1%) | 1 | 2/984 (0.2%) | 2 |
Hypotension | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Hypovolaemic shock | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Peripheral arterial occlusive disease | 1/980 (0.1%) | 1 | 2/984 (0.2%) | 2 |
Peripheral artery occlusion | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Peripheral artery thrombosis | 1/980 (0.1%) | 1 | 0/984 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
Liraglutide 1.8 mg | Oral Antidiabetic Drug | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 65/980 (6.6%) | 15/984 (1.5%) | ||
Gastrointestinal disorders | ||||
Nausea | 65/980 (6.6%) | 82 | 15/984 (1.5%) | 21 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Results Point of Contact
Name/Title | Clinical Reporting Anchor and Disclosure (1452) |
---|---|
Organization | Novo Nordisk A/S |
Phone | (+1) 866-867-7178 |
clinicaltrials@novonordisk.com |
- NN2211-4232
- 2015-002417-29
- U1111-1170-7035