Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2)

• Sponsor: Mylan Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02227875
• Collaborator: Mylan GmbH (Industry)
• Enrollment: 560
• Locations: 120
• Arms: 2
• Duration (Months): 16
• Patients Per Site: 4.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily (both administered in combination with other anti-diabetic drugs) based on the change in HbA1c from baseline to 24 weeks

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Mylan's insulin glargine; Drug: Lantus®	Phase 3

Detailed Description

This trial is a multi-center, open-label, randomized, parallel group trial in patients with T2DM comparing the efficacy and safety of Mylan's insulin glargine with that of Lantus®. Patients with an established diagnosis of T2DM per ADA 2014 criteria and who satisfy the selection criteria will be included in the trial. This will be followed by a 24-week randomized, comparative, parallel-assignment treatment period with Mylan's insulin glargine or Lantus® (in addition to other anti-diabetic drugs). After the treatment period, there will be a follow-up visit; 4 weeks after the patient has been put back on approved medications.

Study Design

• Study Type: Interventional
• Actual Enrollment: 560 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Randomized, Multi-center, Parallel Group Clinical Trial Comparing the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mylan's insulin Glargine receive Mylan's insulin Glargine	Drug: Mylan's insulin glargine; Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
Active Comparator: Lantus® receive Lantus®	Drug: Lantus®; For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Outcome Measures

Primary Outcome Measures

1. Change in HbA1c From Baseline to 24 Weeks [24 weeks]

Secondary Outcome Measures

1. Rate of Hypoglycemic Events Per 30 Days [Baseline and up to 24 weeks]

   The change from baseline at 12 and 24 weeks is reported

2. Hypoglycemia Occurrence [24 weeks]

   Overall hypoglycemic incidence during treatment period

3. Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time [Week 12 and week 24]

   Comparison of change from Baseline in Immunogenicity

4. Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time [week 12 and week 24]

   Comparison of change from Baseline in Immunogenicity

5. Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time [week 12 and week 24]

   Comparison of change from Baseline in Immunogenicity

6. Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time [Week 12 and week 24]

   Comparison of change from Baseline in Immunogenicity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with an established diagnosis of T2DM per ADA 2014 criteria who also fulfill the following:

• Diagnosis established 1 year prior to screening

• Insulin-naïve OR

• On Lantus® once daily at stable dose (±15% variation in dose) for at least 3 months prior to screening

• Body mass index (BMI) of 18.50 to 40.00 kg/m2 at screening (both values inclusive).

• Stable weight, with no more than 5 kg gain or loss, in the 3 months prior to screening; this information will be collected by patient interview during medical history.

• Hemoglobin ≥9.0 g/dL at screening

• Glycosylated hemoglobin (HbA1c) of <10.5% or between 7.5 to 10.5% for insulin naïve patients at screening.

Exclusion Criteria:

• History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analog preparations used in the trial, OR history of significant allergic drug reactions.

• History of use of animal insulin within the last 3 years, any insulin other than Lantus® within the last 3 months prior to screening, or use of biosimilar insulin glargine at any time prior to screening.

• Patients requiring basal-bolus insulin therapy or who in the opinion of the investigator require mealtime insulin in order to achieve glycemic control.

• Regular use of immune-modulator therapy in the 1 year prior to screening.

• History of ≥2 episodes of severe hypoglycemia within the 6 months before screening or history of hypoglycemia unawareness (a sample questionnaire is provided in Appendix I) as judged by the investigator.

• History of ≥1 episode of hyperglycemic hyperosmolar coma or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening.

• Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg) or hepatitis C (HCVAb) antibodies at screening.

• History of drug or alcohol dependence or abuse during the 1 year prior to screening.

• Receipt of another investigational drug in the 3 months prior to screening (or as per local regulations), or if the screening visit is within 5 half-lives of another investigational drug (whichever is longer), or scheduled to receive another investigational drug during the current trial period.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mylan Investigational Site	Chandler	Arizona	United States	85224
2	Mylan Investigational Site	Bell Gardens	California	United States	90201
3	Mylan Investigational Site	Fresno	California	United States	93720
4	Mylan Investigational Site	Greenbrae	California	United States	94904
5	Mylan Investigational Site	Long Beach	California	United States	90807
6	Mylan Investigational Site	Los Angeles	California	United States	90057
7	Mylan Investigational Site	Los Gatos	California	United States	95032
8	Mylan Investigational Site	Mission Hills	California	United States	91345
9	Mylan Investigational Site	National City	California	United States	47304
10	Mylan Investigational Site	Northridge	California	United States	91324
11	Mylan Investigational Site	Orange	California	United States	92868
12	Mylan Investigational Site	Palm Springs	California	United States	92262
13	Mylan Investigational Site	Spring Valley	California	United States	91978
14	Mylan Investigational Site	Tustin	California	United States	92780
15	Mylan Investigational Site	Walnut Creek	California	United States	94598
16	Mylan Investigational Site	West Hills	California	United States	91307
17	Mylan Investigational Site	Bradenton	Florida	United States	34208
18	Mylan Investigational Site	Cooper City	Florida	United States	33024
19	Mylan Investigational Site	Hialeah	Florida	United States	33012
20	Mylan Investigational Site	Miami	Florida	United States	33142
21	Mylan Investigational Site	Miami	Florida	United States	33156
22	Mylan Investigational Site	New Port Richey	Florida	United States	34652
23	Mylan Investigational Site	Palm Harbor	Florida	United States	34684
24	Mylan Investigational Site	Pembroke Pines	Florida	United States	33028
25	Mylan Investigational Site	Port Charlotte	Florida	United States	33952
26	Mylan Investigational Site	West Palm Beach	Florida	United States	33401
27	Mylan Investigational Site	Winter Haven	Florida	United States	33880
28	Mylan Investigational Site	Columbus	Georgia	United States	31904
29	Mylan Investigational Site	Gainesville	Georgia	United States	30501
30	Mylan Investigational Site	Honolulu	Hawaii	United States	96814
31	Mylan Investigational Site	Idaho Falls	Idaho	United States	83404
32	Mylan Investigational Site	Chicago	Illinois	United States	60616
33	Mylan Investigational Site	Crystal Lake	Illinois	United States	60012
34	Mylan Investigational Site	Springfield	Illinois	United States	62704
35	Mylan Investigational Site	Anderson	Indiana	United States	46011
36	Mylan Investigational Site	Council Bluffs	Iowa	United States	51501
37	Mylan Investigational Site	Des Moines	Iowa	United States	50314
38	Mylan Investigational Site	Augusta	Kansas	United States	67010
39	Mylan Investigational Site	Topeka	Kansas	United States	66606
40	Mylan Investigational Site	Wichita	Kansas	United States	67207
41	Mylan Investigational Site	Crestview Hills	Kentucky	United States	41017
42	Mylan Investigational Site	Lexington	Kentucky	United States	40503
43	Mylan Investigational Site	Waltham	Massachusetts	United States	02453
44	Mylan Investigational Site	Kansas City	Missouri	United States	64114
45	Mylan Investigational Site	Saint Louis	Missouri	United States	63128
46	Mylan Investigational Site	Billings	Montana	United States	59101
47	Mylan Investigational Site	Lincoln	Nebraska	United States	68516
48	Mylan Investigational Site	Omaha	Nebraska	United States	68114
49	Mylan Investigational Site	Omaha	Nebraska	United States	68131
50	Mylan Investigational Site	Las Vegas	Nevada	United States	89119
51	Mylan Investigational Site	Las Vegas	Nevada	United States	89128
52	Mylan Investigational Site	Nashua	New Hampshire	United States	03063
53	Mylan Investigational Site	Albany	New York	United States	12206
54	Mylan Investigational Site	Hartsdale	New York	United States	10530
55	Mylan Investigational Site	Smithtown	New York	United States	11787
56	Mylan Investigational Site	Staten Island	New York	United States	10301
57	Mylan Investigational Site	Asheville	North Carolina	United States	28803
58	Mylan Investigational Site	Burlington	North Carolina	United States	27215
59	Mylan Investigational Site	Cary	North Carolina	United States	27513
60	Mylan Investigational Site	Greensboro	North Carolina	United States	27408
61	Mylan Investigational Site	Greenville	North Carolina	United States	28590
62	Mylan Investigational Site	Hickory	North Carolina	United States	28601
63	Mylan Investigational Site	Morehead City	North Carolina	United States	28557
64	Mylan Investigational Site	Wilmington	North Carolina	United States	28401
65	Mylan Investigational Site	Cincinnati	Ohio	United States	45236
66	Mylan Investigational Site	Cleveland	Ohio	United States	44122
67	Mylan Investigational Site	Columbus	Ohio	United States	43201
68	Mylan Investigational Site	Bend	Oregon	United States	97701
69	Mylan Investigational Site	Charleston	South Carolina	United States	29407
70	Mylan Investigational Site	Greer	South Carolina	United States	29651
71	Mylan Investigational Site	Bristol	Tennessee	United States	34208
72	Mylan Investigational Site	Kingsport	Tennessee	United States	37660
73	Mylan Investigational Site	Memphis	Tennessee	United States	38119
74	Mylan Investigational Site	Austin	Texas	United States	78731
75	Mylan Investigational Site	Corpus Christi	Texas	United States	78404
76	Mylan Investigational Site	Dallas	Texas	United States	75230
77	Mylan Investigational Site	Dallas	Texas	United States	75231
78	Mylan Investigational Site	El Paso	Texas	United States	79925
79	Mylan Investigational Site	Houston	Texas	United States	77004
80	Mylan Investigational Site	Houston	Texas	United States	77095
81	Mylan Investigational Site	McKinney	Texas	United States	75070
82	Mylan Investigational Site	Round Rock	Texas	United States	78681
83	Mylan Investigational Site	San Antonio	Texas	United States	78258
84	Mylan Investigational Site	Spring	Texas	United States	77379
85	Mylan Investigational Site	Victoria	Texas	United States	77901
86	Mylan Investigational Site	Ogden	Utah	United States	84405
87	Mylan Investigational Site	Salt Lake City	Utah	United States	84102
88	Mylan Investigational Site	Salt Lake City	Utah	United States	84109
89	Mylan Investigational Site	Salt Lake City	Utah	United States	84121
90	Mylan Investigational Site	South Jordan	Utah	United States	84095
91	Mylan Investigational Site	Chesapeake	Virginia	United States	23321
92	Mylan Investigational Site	Manassas	Virginia	United States	20110
93	Mylan Investigational Site	Tacoma	Washington	United States	98405
94	Mylan Investigational Site	Vancouver	Washington	United States	98405
95	Mylan Investigational Site	Amman		Jordan
96	Mylan Investigational Site	Irbid		Jordan
97	Mylan Investigational Site	Seoul	Gyeonggi-do	Korea, Republic of
98	Mylan Investigational Site	Suwon-si	Gyeonggi-do	Korea, Republic of
99	Mylan Investigational Site	Seoul		Korea, Republic of	110744
100	Mylan Investigational Site	Banska Bystrica		Slovakia
101	Mylan Investigational Site	Bardejov		Slovakia
102	Mylan Investigational Site	Bratislava		Slovakia
103	Mylan Investigational Site	Dolny Kubin		Slovakia
104	Mylan Investigational Site	Kosice		Slovakia
105	Mylan Investigational Site	Levice		Slovakia
106	Mylan Investigational Site	Sabinov		Slovakia
107	Mylan Investigational Site	Sahy		Slovakia
108	Mylan Investigational Site	Stropkov		Slovakia
109	Mylan Investigational Site	Sturovo		Slovakia
110	Mylan Investigational Site	Trebisov		Slovakia
111	Mylan Investigational Site	Trencin		Slovakia
112	Mylan Investigational Site	Zilina		Slovakia
113	Mylan Investigational Site	Johannesburg	Gauteng	South Africa
114	Mylan Investigational Site	Durban	KwaZulu-Natal	South Africa
115	Mylan Investigational Site	Cape Town	Western Cape	South Africa	7646
116	Mylan Investigational Site	Cape Town	Western Cape	South Africa
117	Mylan Investigational Site	Worcester	Western Cape	South Africa
118	Mylan Investigational Site	Bloemfontein		South Africa
119	Mylan Investigational Site	Kaohsiung		Taiwan
120	Mylan Investigational Site	Taipei		Taiwan

Sponsors and Collaborators

• Mylan Inc.
• Mylan GmbH

Investigators

• Principal Investigator: Thomas Blevins, MD, Texas Diabetes & Endocrinology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mylan Inc.
• ClinicalTrials.gov Identifier: NCT02227875
• Other Study ID Numbers: MYL-GAI-3002
• First Posted: Aug 28, 2014
• Last Update Posted: Mar 3, 2022
• Last Verified: Mar 1, 2022

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Glargine

Study Results

Participant Flow

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
Period Title: Overall Study
STARTED	277	283
COMPLETED	240	250
NOT COMPLETED	37	33

Baseline Characteristics

Arm/Group Title	Mylan's Insulin Glargine	Lantus®	Total
Arm/Group Description	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.	Total of all reporting groups
Overall Participants	277	283	560
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	267 96.4%	267 94.3%	534 95.4%
>=65 years	10 3.6%	16 5.7%	26 4.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55 (7.91)	55.1 (7.5)	55.1 (7.7)
Sex: Female, Male (Count of Participants)
Female	130 46.9%	118 41.7%	248 44.3%
Male	147 53.1%	165 58.3%	312 55.7%
Region of Enrollment (participants) [Number]
South Korea	3 1.1%	4 1.4%	7 1.3%
United States	225 81.2%	228 80.6%	453 80.9%
Taiwan	1 0.4%	0 0%	1 0.2%
South Africa	12 4.3%	15 5.3%	27 4.8%
Slovakia	34 12.3%	33 11.7%	67 12%
Jordan	2 0.7%	3 1.1%	5 0.9%

Outcome Measures

1. Primary Outcome

Title	Change in HbA1c From Baseline to 24 Weeks
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
Measure Participants	274	278
Least Squares Mean (95% Confidence Interval) [percent]	-0.6	-0.66

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mylan's Insulin Glargine, Lantus®
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Mixed-Effect Model for Repeated Measures
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 95%; -0.098 to 0.218
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

2. Secondary Outcome

Title	Rate of Hypoglycemic Events Per 30 Days
Description	The change from baseline at 12 and 24 weeks is reported
Time Frame	Baseline and up to 24 weeks

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
Measure Participants	276	282
week 12	0.341 (1.8963)	0.24 (2.0551)
week 24	-0.057 (0.919)	-0.102 (1.6791)

3. Secondary Outcome

Title	Hypoglycemia Occurrence
Description	Overall hypoglycemic incidence during treatment period
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
Measure Participants	276	282
Any hypoglycemic event	130	136
Severe Hypoglycemia	0	1
Documented Symptomatic Hypoglycemia	75	76
Asymptomatic Hypoglycemia	85	92
Probable Symptomatic Hypoglycemia	7	4
Relative Hypoglycemia	20	11
Unknown	29	25

4. Secondary Outcome

Title	Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
Description	Comparison of change from Baseline in Immunogenicity
Time Frame	Week 12 and week 24

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
Measure Participants	276	282
week 12	1.9238 (12.54369)	0.6585 (8.05473)
week 24	1.7802 (9.64745)	0.7838 (8.15086)

5. Secondary Outcome

Title	Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time
Description	Comparison of change from Baseline in Immunogenicity
Time Frame	week 12 and week 24

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
Measure Participants	276	282
week 12	1.787 (11.67578)	0.6462 (7.56375)
week 24	1.6866 (9.57132)	0.8212 (8.1084)

6. Secondary Outcome

Title	Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
Description	Comparison of change from Baseline in Immunogenicity
Time Frame	week 12 and week 24

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
Measure Participants	276	282
week 12	1.7488 (11.68129)	0.5116 (7.25175)
week 24	1.6301 (9.11098)	0.7524 (7.93317)

7. Secondary Outcome

Title	Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time
Description	Comparison of change from Baseline in Immunogenicity
Time Frame	Week 12 and week 24

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
Measure Participants	276	282
week 12	1.5994 (10.64782)	0.5014 (6.72058)
week 24	1.5648 (9.04243)	0.8361 (7.96308)

Adverse Events

Time Frame	24 weeks
Arm/Group Title	Mylan's Insulin Glargine		Lantus®
Arm/Group Description	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.		receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
All Cause Mortality
	Mylan's Insulin Glargine		Lantus®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/276 (0%)		0/282 (0%)
Serious Adverse Events
	Mylan's Insulin Glargine		Lantus®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/276 (2.9%)		9/282 (3.2%)
Eye disorders
Eye haemorrhage	1/276 (0.4%)	1	0/282 (0%)	0
Gastrointestinal disorders
Gastric ulcer	1/276 (0.4%)	1	0/282 (0%)	0
Pancreatitis	1/276 (0.4%)	1	0/282 (0%)	0
Pancreatitis acute	1/276 (0.4%)	1	0/282 (0%)	0
General disorders
Non-cardiac chest pain	1/276 (0.4%)	1	0/282 (0%)	0
Infections and infestations
Bronchitis	1/276 (0.4%)	1	1/282 (0.4%)	1
Meningitis viral	0/276 (0%)	0	1/282 (0.4%)	1
Paraspinal abscess	1/276 (0.4%)	1	0/282 (0%)	0
Investigations
Helicobacter test positive	1/276 (0.4%)	1	0/282 (0%)	0
Hepatic enzyme increased	1/276 (0.4%)	1	0/282 (0%)	0
Metabolism and nutrition disorders
Dehydration	0/276 (0%)	0	1/282 (0.4%)	1
Hyperosmolar hyperglycaemic state	0/276 (0%)	0	1/282 (0.4%)	1
Hypoglycaemia	0/276 (0%)	0	1/282 (0.4%)	2
Lactic acidosis	0/276 (0%)	0	1/282 (0.4%)	1
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis	1/276 (0.4%)	1	0/282 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma	0/276 (0%)	0	1/282 (0.4%)	1
Squamous cell carcinoma of skin	0/276 (0%)	0	1/282 (0.4%)	2
Nervous system disorders
Cerebrovascular accident	0/276 (0%)	0	1/282 (0.4%)	1
Renal and urinary disorders
Acute kidney injury	0/276 (0%)	0	2/282 (0.7%)	2
Respiratory, thoracic and mediastinal disorders
Asthma	1/276 (0.4%)	1	0/282 (0%)	0
Chronic obstructive pulmonary	0/276 (0%)	0	1/282 (0.4%)	1
Hypoxia	1/276 (0.4%)	1	0/282 (0%)	0
Other (Not Including Serious) Adverse Events
	Mylan's Insulin Glargine		Lantus®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	177/276 (64.1%)		164/282 (58.2%)
Gastrointestinal disorders
Nausea	6/276 (2.2%)	6	4/282 (1.4%)	4
Vomiting	5/276 (1.8%)	5	5/282 (1.8%)	5
Diarrhoea	4/276 (1.4%)	4	5/282 (1.8%)	10
Abdominal pain	4/276 (1.4%)	4	1/282 (0.4%)	1
Constipation	3/276 (1.1%)	5	0/282 (0%)	0
Dyspepsia	3/276 (1.1%)	3	0/282 (0%)	0
Gastrooesophageal reflux disease	1/276 (0.4%)	1	3/282 (1.1%)	3
General disorders
Fatigue	4/276 (1.4%)	4	2/282 (0.7%)	2
Injection site pain	3/276 (1.1%)	4	2/282 (0.7%)	3
Oedema peripheral	2/276 (0.7%)	2	6/282 (2.1%)	6
Immune system disorders
Seasonal allergy	1/276 (0.4%)	1	4/282 (1.4%)	4
Infections and infestations
Upper respiratory tract infection	17/276 (6.2%)	19	15/282 (5.3%)	15
Urinary tract infection	12/276 (4.3%)	13	8/282 (2.8%)	8
Nasopharyngitis	10/276 (3.6%)	11	13/282 (4.6%)	14
Sinusitis	8/276 (2.9%)	9	4/282 (1.4%)	5
Influenza	6/276 (2.2%)	7	3/282 (1.1%)	3
Bronchitis	5/276 (1.8%)	5	7/282 (2.5%)	7
Gastroenteritis	5/276 (1.8%)	5	1/282 (0.4%)	1
Pharyngitis	3/276 (1.1%)	3	1/282 (0.4%)	1
Pneumonia	3/276 (1.1%)	3	0/282 (0%)	0
Vulvovaginal mycotic infection	3/276 (1.1%)	3	0/282 (0%)	0
Injury, poisoning and procedural complications
Contusion	1/276 (0.4%)	1	4/282 (1.4%)	4
Laceration	0/276 (0%)	0	4/282 (1.4%)	4
Investigations
Lipase increased	4/276 (1.4%)	4	1/282 (0.4%)	1
Metabolism and nutrition disorders
Hypoglycemia	75/276 (27.2%)	330	66/282 (23.4%)	282
Musculoskeletal and connective tissue disorders
Back pain	7/276 (2.5%)	7	6/282 (2.1%)	6
Pain in extremity	5/276 (1.8%)	5	4/282 (1.4%)	4
Arthralgia	4/276 (1.4%)	4	5/282 (1.8%)	7
Musculoskeletal pain	2/276 (0.7%)	2	5/282 (1.8%)	5
Nervous system disorders
Headache	8/276 (2.9%)	9	10/282 (3.5%)	11
Tremor	6/276 (2.2%)	9	1/282 (0.4%)	3
Dizziness	4/276 (1.4%)	4	7/282 (2.5%)	8
Renal and urinary disorders
Nephrolithiasis	3/276 (1.1%)	3	0/282 (0%)	0
Dysuria	0/276 (0%)	0	3/282 (1.1%)	3
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	5/276 (1.8%)	5	5/282 (1.8%)	5
Cough	4/276 (1.4%)	4	10/282 (3.5%)	10
Respiratory tract congestion	3/276 (1.1%)	3	0/282 (0%)	0
Skin and subcutaneous tissue disorders
Rash	2/276 (0.7%)	3	3/282 (1.1%)	3
Pruritus	1/276 (0.4%)	1	3/282 (1.1%)	3
Vascular disorders
Hypertension	6/276 (2.2%)	6	2/282 (0.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.