EDITION I: Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01499082
• Collaborator: (none)
• Enrollment: 807
• Locations: 193
• Arms: 2
• Duration (Months): 21
• Patients Per Site: 4.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Primary Objective:

• To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus

Secondary Objectives:

• To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal Hypoglycemia

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: HOE901-U300 (new formulation of insulin glargine); Drug: Lantus (insulin glargine)	Phase 3

Detailed Description

The maximum study duration was up to approximately 58 weeks per participant, consisting of:

• up to 2 week screening period

• 6-month comparative efficacy and safety treatment period

• 6-month comparative safety extension period

• 4-week safety follow-up period in a subset of participants

• a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to HOE901-U300

Study Design

• Study Type: Interventional
• Actual Enrollment: 807 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both Plus Mealtime Insulin in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HOE901-U300	Drug: HOE901-U300 (new formulation of insulin glargine); HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter [mg/dL]). After 6 months participants were proposed to participate to the administration substudy and to receive either HOE901-U300 once daily at intervals of 24 +/- 3 hours (adaptable dosing intervals) or to continue once daily injections of HOE901-U300 every 24 hours (fixed dosing intervals) up to Month 9.
Active Comparator: Lantus	Drug: Lantus (insulin glargine); Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).; Other Names: Lantus

Outcome Measures

Primary Outcome Measures

1. Change in HbA1c From Baseline to Month 6 Endpoint [Baseline, Month 6]

Secondary Outcome Measures

1. Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint [Week 9 Up to Month 6]

   Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]).

2. Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint [Baseline, Month 6]

   Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.

3. Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint [Baseline, Month 6]

   Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.

4. Percentage of Participants With HbA1c <7% at Month 6 Endpoint [Month 6]

5. Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint [Baseline, Month 6]

6. Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint [Month 6]

7. Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint [Baseline, Month 6]

   Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.

8. Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint [Baseline, Month 6]

9. Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint [Baseline, Month 6]

   DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.

10. Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 [Up to Month 12]

    Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).

Other Outcome Measures

1. Change in HbA1c From Month 6 to Month 9 [Month 6 Up to Month 9]

   Substudy comparing fixed dosing regimen (every 24 hours) vs. adaptive dosing regimen (every 24 +/- 3 hours) in a subset of participants randomized to HOE901-U300 and treated for 6 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria :

• Participants with type 2 diabetes mellitus

• Substudy inclusion criteria:

• Completion of the 6-month study period in main study (Visit 10)

• Randomized and treated with insulin glargine new formulation during the 6-month treatment period (Baseline - month 6)

Exclusion criteria:

• Age less than (<) 18 years

• HbA1c <7.0% or greater than (>) 10% at screening

• Diabetes other than type 2 diabetes mellitus

• Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose

• Any contraindication to use of insulin glargine as defined in the national product label

• Participants using human regular insulin as mealtime insulin in the last 3 months before screening visit

• Use of an insulin pump in the last 6 months before screening visit

• Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before screening visit

• History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period

• Pregnant or breast-feeding women or women who intend to become pregnant during the study period

• Substudy exclusion criteria:

• Participant not willing to use the adaptable injection intervals on at least two days per week

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number 840156	Chandler	Arizona	United States	85224
2	Investigational Site Number 840102	Glendale	Arizona	United States	85306
3	Investigational Site Number 840071	Phoenix	Arizona	United States	85028
4	Investigational Site Number 840121	Sun City	Arizona	United States	85351
5	Investigational Site Number 840070	Tempe	Arizona	United States	85282
6	Investigational Site Number 840016	Hot Springs	Arkansas	United States	71913
7	Investigational Site Number 840015	Little Rock	Arkansas	United States	72205
8	Investigational Site Number 840124	Little Rock	Arkansas	United States	72205
9	Investigational Site Number 840032	Searcy	Arkansas	United States	72143
10	Investigational Site Number 840076	Anaheim	California	United States	92801
11	Investigational Site Number 840133	Encino	California	United States	91436
12	Investigational Site Number 840062	Greenbrae	California	United States	94904
13	Investigational Site Number 840057	Huntington Beach	California	United States	92648
14	Investigational Site Number 840059	La Jolla	California	United States	92037
15	Investigational Site Number 840004	La Mesa	California	United States	91942
16	Investigational Site Number 840099	Mission Hills	California	United States	91345
17	Investigational Site Number 840107	Palm Springs	California	United States	92262
18	Investigational Site Number 840005	San Diego	California	United States	92161
19	Investigational Site Number 840013	Tustin	California	United States	92780
20	Investigational Site Number 840002	Walnut Creek	California	United States	94598
21	Investigational Site Number 840114	Colorado Springs	Colorado	United States	80906
22	Investigational Site Number 840136	Colorado Springs	Colorado	United States	80910
23	Investigational Site Number 840092	Longmont	Colorado	United States	80501
24	Investigational Site Number 840049	Daytona Beach	Florida	United States	32117
25	Investigational Site Number 840050	Hollywood	Florida	United States	33021
26	Investigational Site Number 840086	Jacksonville	Florida	United States	32204
27	Investigational Site Number 840011	Jacksonville	Florida	United States	32216
28	Investigational Site Number 840009	Jacksonville	Florida	United States	32258
29	Investigational Site Number 840023	New Port Richey	Florida	United States	34652
30	Investigational Site Number 840012	Ocoee	Florida	United States	34761
31	Investigational Site Number 840148	Palm Harbor	Florida	United States	34684
32	Investigational Site Number 840055	Lawrenceville	Georgia	United States	30045
33	Investigational Site Number 840052	Idaho Falls	Idaho	United States	83404
34	Investigational Site Number 840117	Nampa	Idaho	United States	83686
35	Investigational Site Number 840020	McHenry	Illinois	United States	60050
36	Investigational Site Number 840019	Springfield	Illinois	United States	62704
37	Investigational Site Number 840078	Avon	Indiana	United States	46123
38	Investigational Site Number 840089	Avon	Indiana	United States	46123
39	Investigational Site Number 840097	Avon	Indiana	United States	46123
40	Investigational Site Number 840098	Avon	Indiana	United States	46123
41	Investigational Site Number 840100	Avon	Indiana	United States	46123
42	Investigational Site Number 840127	Vincennes	Indiana	United States	47591
43	Investigational Site Number 840116	Des Moines	Iowa	United States	50314
44	Investigational Site Number 840003	Wichita	Kansas	United States	67211
45	Investigational Site Number 840080	Lexington	Kentucky	United States	40504
46	Investigational Site Number 840042	Paducah	Kentucky	United States	42003
47	Investigational Site Number 840036	Baltimore	Maryland	United States	21237
48	Investigational Site Number 840155	Baltimore	Maryland	United States	21237
49	Investigational Site Number 840034	Rockville	Maryland	United States	20852
50	Investigational Site Number 840065	Ann Arbor	Michigan	United States	48106
51	Investigational Site Number 840066	Dearborn	Michigan	United States	48124
52	Investigational Site Number 840103	Flint	Michigan	United States	48504
53	Investigational Site Number 840126	Kalamazoo	Michigan	United States	49048
54	Investigational Site Number 840022	Southfield	Michigan	United States	48034
55	Investigational Site Number 840143	Chaska	Minnesota	United States	55318
56	Investigational Site Number 840068	Eagan	Minnesota	United States	55122
57	Investigational Site Number 840085	Minneapolis	Minnesota	United States	55416
58	Investigational Site Number 840053	Kalispell	Montana	United States	59901
59	Investigational Site Number 840090	Fremont	Nebraska	United States	68025
60	Investigational Site Number 840091	Omaha	Nebraska	United States	68130
61	Investigational Site Number 840058	Las Vegas	Nevada	United States	89148
62	Investigational Site Number 840043	Brick	New Jersey	United States	08274
63	Investigational Site Number 840152	Toms River	New Jersey	United States	08721
64	Investigational Site Number 840146	Asheville	North Carolina	United States	28801
65	Investigational Site Number 840145	Hickory	North Carolina	United States	28601
66	Investigational Site Number 840045	Wilmington	North Carolina	United States	28401
67	Investigational Site Number 840067	Fargo	North Dakota	United States	58103
68	Investigational Site Number 840008	Cincinnati	Ohio	United States	45236
69	Investigational Site Number 840106	Columbus	Ohio	United States	43213
70	Investigational Site Number 840123	Dayton	Ohio	United States	45439
71	Investigational Site Number 840119	Maumee	Ohio	United States	43537
72	Investigational Site Number 840122	Mentor	Ohio	United States	44060
73	Investigational Site Number 840083	Medford	Oregon	United States	97504
74	Investigational Site Number 840084	Portland	Oregon	United States	97239-3098
75	Investigational Site Number 840007	Uniontown	Pennsylvania	United States	15401
76	Investigational Site Number 840079	Greer	South Carolina	United States	29651
77	Investigational Site Number 840048	Rapid City	South Dakota	United States	57701
78	Investigational Site Number 840039	Chattanooga	Tennessee	United States	37404
79	Investigational Site Number 840159	Knoxville	Tennessee	United States	37912
80	Investigational Site Number 840021	Austin	Texas	United States	78731
81	Investigational Site Number 840129	Austin	Texas	United States	78731
82	Investigational Site Number 840081	Austin	Texas	United States	78758
83	Investigational Site Number 840001	Dallas	Texas	United States	75230
84	Investigational Site Number 840047	Dallas	Texas	United States	75246
85	Investigational Site Number 840082	Houston	Texas	United States	77096
86	Investigational Site Number 840120	Hurst	Texas	United States	76054
87	Investigational Site Number 840010	Draper	Utah	United States	84020
88	Investigational Site Number 840060	Ogden	Utah	United States	84403
89	Investigational Site Number 840035	Chesapeake	Virginia	United States	23321
90	Investigational Site Number 840074	Norfolk	Virginia	United States	23502
91	Investigational Site Number 840112	Norfolk	Virginia	United States	23507
92	Investigational Site Number 840041	Norfolk	Virginia	United States	23510
93	Investigational Site Number 840104	Richmond	Virginia	United States	23235
94	Investigational Site Number 840075	Williamsburg	Virginia	United States	23185
95	Investigational Site Number 840018	Milwaukee	Wisconsin	United States	53209-0996
96	Investigational Site Number 124024	Beamsville		Canada	L0R 1B0
97	Investigational Site Number 124025	Burlington		Canada	L7M 4Y1
98	Investigational Site Number 124023	Calgary		Canada	T2H 2G4
99	Investigational Site Number 124020	Calgary		Canada	T2N 4L7
100	Investigational Site Number 124019	Chatham		Canada	N7L 1C1
101	Investigational Site Number 124018	Coquitlam		Canada	V3K 3P4
102	Investigational Site Number 124021	Hamilton		Canada	L8L 5G8
103	Investigational Site Number 124014	Hamilton		Canada	L8N 3Z5
104	Investigational Site Number 124006	Laval		Canada	H7T 2P5
105	Investigational Site Number 124009	London		Canada	N6A 4V2
106	Investigational Site Number 124008	Mississauga		Canada	L5M 2V8
107	Investigational Site Number 124015	Montreal		Canada	H2W 1R7
108	Investigational Site Number 124004	Montreal		Canada	H2W 1T8
109	Investigational Site Number 124005	Oshawa		Canada	L1H 7K4
110	Investigational Site Number 124026	Quebec		Canada	G1V 4G5
111	Investigational Site Number 124002	Red Deer		Canada	T4N 6V7
112	Investigational Site Number 124007	Thornhill		Canada	L4J 8L7
113	Investigational Site Number 124001	Toronto		Canada	M4G 3E8
114	Investigational Site Number 124011	Toronto		Canada	M5C 2T2
115	Investigational Site Number 124010	Victoria		Canada	V8V 4A1
116	Investigational Site Number 124017	Ville St-Laurent		Canada	H4T 1Z9
117	Investigational Site Number 124022	Winnipeg		Canada	R3E 3P4
118	Investigational Site Number 203006	Beroun		Czechia	26601
119	Investigational Site Number 203001	Breclav		Czechia	690 02
120	Investigational Site Number 203002	Hodonin		Czechia	69501
121	Investigational Site Number 203009	Holesov		Czechia	76901
122	Investigational Site Number 203003	Hradec Kralove		Czechia	50005
123	Investigational Site Number 203007	Hranice		Czechia	75301
124	Investigational Site Number 203004	Krnov		Czechia	79401
125	Investigational Site Number 203010	Olomouc		Czechia	77900
126	Investigational Site Number 203008	Praha 2		Czechia	12808
127	Investigational Site Number 203005	Prostejov		Czechia	79601
128	Investigational Site Number 233002	Pärnu		Estonia	80018
129	Investigational Site Number 233004	Tallinn		Estonia	11313
130	Investigational Site Number 233006	Tallinn		Estonia	11913
131	Investigational Site Number 233003	Tallinn		Estonia	13415
132	Investigational Site Number 233001	Tallinn		Estonia	13419
133	Investigational Site Number 233005	Tartu		Estonia	50410
134	Investigational Site Number 246001	Helsinki		Finland	00260
135	Investigational Site Number 246005	Kuopio		Finland	70210
136	Investigational Site Number 246002	Oulu		Finland	90100
137	Investigational Site Number 250004	La Rochelle Cedex		France	17019
138	Investigational Site Number 250002	Strasbourg		France	67091
139	Investigational Site Number 276006	Heidelberg		Germany	69115
140	Investigational Site Number 276002	Riesa		Germany	01587
141	Investigational Site Number 276003	Schwabenheim		Germany	55270
142	Investigational Site Number 348010	Baja		Hungary	6500
143	Investigational Site Number 348004	Balatonfüred		Hungary	8230
144	Investigational Site Number 348015	Budapest		Hungary	1083
145	Investigational Site Number 348013	Budapest		Hungary	1088
146	Investigational Site Number 348017	Budapest		Hungary	1134
147	Investigational Site Number 348009	Budapest		Hungary	1139
148	Investigational Site Number 348002	Budapest		Hungary
149	Investigational Site Number 348005	Debrecen		Hungary	4043
150	Investigational Site Number 348008	Eger		Hungary	3300
151	Investigational Site Number 348018	Gyula		Hungary	5700
152	Investigational Site Number 348014	Makó		Hungary	6900
153	Investigational Site Number 348012	Mosonmagyaróvár		Hungary	9200
154	Investigational Site Number 348007	Nyiregyháza		Hungary	4400
155	Investigational Site Number 348003	Szeged		Hungary	6722
156	Investigational Site Number 348006	Szombathely		Hungary	9700
157	Investigational Site Number 348011	Sátorlaljaújhely		Hungary	3980
158	Investigational Site Number 348001	Zalaegerszeg		Hungary	8900
159	Investigational Site Number 428006	Jekabpils		Latvia	LV-5201
160	Investigational Site Number 428005	Ogre		Latvia	LV-5001
161	Investigational Site Number 428002	Riga		Latvia	LV-1002
162	Investigational Site Number 428001	Riga		Latvia	LV-1038
163	Investigational Site Number 428004	Riga		Latvia	LV-1050
164	Investigational Site Number 428003	Sigulda		Latvia	LV-2150
165	Investigational Site Number 484007	Chihuahua		Mexico	31000
166	Investigational Site Number 484001	Cuernavaca		Mexico	62250
167	Investigational Site Number 484006	Guadalajara		Mexico	44670
168	Investigational Site Number 484003	Monterrey		Mexico	64460
169	Investigational Site Number 484004	Pachuca		Mexico	42060
170	Investigational Site Number 528009	Almelo		Netherlands	7609 PP
171	Investigational Site Number 528004	Eindhoven		Netherlands	5631 BM
172	Investigational Site Number 528007	Groningen		Netherlands	9728 NT
173	Investigational Site Number 528005	Hoogeveen		Netherlands	7909 AA
174	Investigational Site Number 528001	Hoorn		Netherlands	1064NP
175	Investigational Site Number 528008	Leeuwarden		Netherlands	8934 AD
176	Investigational Site Number 528006	Utrecht		Netherlands	3563 AZ
177	Investigational Site Number 528002	Venlo		Netherlands	5912 BL
178	Investigational Site Number 642001	Bacau		Romania	600114
179	Investigational Site Number 642005	Bucuresti		Romania	020475
180	Investigational Site Number 642006	Bucuresti		Romania	700164
181	Investigational Site Number 642002	Cluj Napoca		Romania	400006
182	Investigational Site Number 642004	Iasi		Romania	700547
183	Investigational Site Number 642008	Iasi		Romania	700613
184	Investigational Site Number 642003	Oradea		Romania	410169
185	Investigational Site Number 642009	Targu Mures		Romania	540142
186	Investigational Site Number 642007	Timisoara		Romania	300133
187	Investigational Site Number 710005	Alberton		South Africa	1450
188	Investigational Site Number 710003	Johannesburg		South Africa	2198
189	Investigational Site Number 710006	Lenasia		South Africa	1820
190	Investigational Site Number 710002	Observatory		South Africa	7925
191	Investigational Site Number 710001	Paarl		South Africa	7500
192	Investigational Site Number 710008	Pretoria		South Africa	0167
193	Investigational Site Number 710004	Somerset West		South Africa	7130

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT01499082
• Other Study ID Numbers: EFC11628; 2010-023769-23
• First Posted: Dec 26, 2011
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin; Insulin, Globin Zinc; Insulin Glargine

Study Results

Participant Flow

Recruitment Details	A total of 1177 participants were screened, of whom 370 participants were screen failure and 807 participants were randomized.
Pre-assignment Detail	Following the main 6 month treatment period, eligible participants previously using HOE901-U300 were randomized (1:1) in a substudy and continued with fixed-dosing (every 24 hours) or started a adaptable-dosing (at intervals of 24 +/- 3 hours) regimen for 3 Months (Month 6 to 9).

Arm/Group Title	HOE901-U300	Lantus
Arm/Group Description	HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months on top of mealtime insulin analogue.	Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of mealtime insulin analogue.
Period Title: Overall Study
STARTED	404	403
Treated	404	402
Participated in Substudy	109	0
Modified Intent-to-Treat Population	404	400
COMPLETED	359	355
NOT COMPLETED	45	48

Baseline Characteristics

Arm/Group Title	HOE901-U300	Lantus	Total
Arm/Group Description	HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus SC injection once daily for 12 months on top of mealtime insulin.	Total of all reporting groups
Overall Participants	404	403	807
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.1 (8.5)	59.8 (8.7)	60.0 (8.6)
Sex: Female, Male (Count of Participants)
Female	187 46.3%	193 47.9%	380 47.1%
Male	217 53.7%	210 52.1%	427 52.9%
Body Mass Index (BMI) (kilogram per square meter (kg/m^2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram per square meter (kg/m^2)]	36.6 (6.8)	36.6 (6.1)	36.6 (6.4)
Duration of Diabetes (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.6 (7.2)	16.1 (7.8)	15.8 (7.5)
Basal Insulin Daily Dose (units per kilogram (U/kg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units per kilogram (U/kg)]	0.668 (0.263)	0.667 (0.241)	0.668 (0.252)
Total Insulin Daily Dose (U/kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [U/kg]	1.194 (0.483)	1.200 (0.448)	1.197 (0.466)
Glycated Hemoglobin A1c (HbA1c) (participants) [Number]
Less Than (<) 8%	144 35.6%	144 35.7%	288 35.7%
Greater Than or Equal to (>=) 8%	260 64.4%	259 64.3%	519 64.3%

Outcome Measures

1. Primary Outcome

Title	Change in HbA1c From Baseline to Month 6 Endpoint
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat population: all randomized participants who received at least (>=)1 dose, had baseline and >=1 post-baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Week 6 HbA1c assessment. Missing data imputed using last observation carried forward.

Arm/Group Title	HOE901-U300	Lantus
Arm/Group Description	HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus SC injection once daily for 12 months on top of mealtime insulin.
Measure Participants	391	394
Least Squares Mean (Standard Error) [percentage of hemoglobin]	-0.83 (0.060)	-0.83 (0.061)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HOE901-U300, Lantus
	Comments	Analysis was performed using an analysis of covariance (ANCOVA) model with treatment, strata of screening HbA1c (<8.0 and >=8.0%), and country as fixed effects and using the HbA1c baseline value as a covariate.
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially: Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is <0.4%. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is <0.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least Squares (LS) Mean Difference
	Estimated Value	-0.00
	Confidence Interval	(2-Sided) 95%; -0.112 to 0.107
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.056
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint
Description	Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]).
Time Frame	Week 9 Up to Month 6

Outcome Measure Data

Analysis Population Description

Modified intent-to-treat population.

Arm/Group Title	HOE901-U300	Lantus
Arm/Group Description	HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus SC injection once daily for 12 months on top of mealtime insulin.
Measure Participants	404	400
Number [percentage of participants]	36.1 8.9%	46.0 11.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HOE901-U300, Lantus
	Comments	A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with treatment as a factor and stratified on strata of screening HbA1c (<8.0 and >=8.0%).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0045
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95%; 0.67 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint
Description	Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.

Arm/Group Title	HOE901-U300	Lantus
Arm/Group Description	HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus SC injection once daily for 12 months on top of mealtime insulin.
Measure Participants	365	360
Least Squares Mean (Standard Error) [mmol/L]	-0.90 (0.182)	-0.84 (0.182)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HOE901-U300, Lantus
	Comments	Change in pre-injection SMPG was analyzed using an ANCOVA model with treatment, strata of screening HbA1c (<8.0 and >=8.0%), and country as fixed effects and using the pre-injection SMPG baseline value as a covariate. A test for superiority of HOE901-U300 over Lantus was to be performed one-sided at level alpha = 0.025 if previous analysis for nocturnal hypoglycemia was significant.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.6909
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 95%; -0.383 to 0.254
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.162
	Estimation Comments

4. Secondary Outcome

Title	Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint
Description	Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.

Arm/Group Title	HOE901-U300	Lantus
Arm/Group Description	HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus SC injection once daily for 12 months on top of mealtime insulin.
Measure Participants	365	360
Least Squares Mean (Standard Error) [percentage of mean]	-1.10 (1.222)	-1.08 (1.222)

5. Secondary Outcome

Title	Percentage of Participants With HbA1c <7% at Month 6 Endpoint
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

mITT Population. Number of participants analyzed = participants with baseline and Month 6 HbA1c assessment. Missing data imputed using last observation carried forward.

Arm/Group Title	HOE901-U300	Lantus
Arm/Group Description	HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus SC injection once daily for 12 months on top of mealtime insulin.
Measure Participants	391	394
Number [percentage of participants]	39.6 9.8%	40.9 10.1%

6. Secondary Outcome

Title	Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment. Missing data imputed using last observation carried forward.

Arm/Group Title	HOE901-U300	Lantus
Arm/Group Description	HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus SC injection once daily for 12 months on top of mealtime insulin.
Measure Participants	376	385
Least Squares Mean (Standard Error) [mmol/L]	-1.29 (0.191)	-1.38 (0.192)

7. Secondary Outcome

Title	Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

mITT Population. Number of participants analyzed = participants with Month 6 FPG assessment. Missing data imputed using last observation carried forward.

Arm/Group Title	HOE901-U300	Lantus
Arm/Group Description	HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus SC injection once daily for 12 months on top of mealtime insulin.
Measure Participants	389	392
Number [percentage of participants]	26.5 6.6%	23.2 5.8%

8. Secondary Outcome

Title	Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint
Description	Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

mITT Population. Here, n = participants with Baseline and Month 6 8-point SMPG assessment separately for each analysed time point. Missing data imputed using last observation carried forward.

Arm/Group Title	HOE901-U300	Lantus
Arm/Group Description	HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus SC injection once daily for 12 months on top of mealtime insulin.
Measure Participants	404	400
03:00 at Night Plasma Glucose (n=333,323)	-0.98 (0.248)	-1.16 (0.251)
Pre-Breakfast Plasma Glucose (n=343,333)	-1.19 (0.189)	-1.49 (0.190)
2 Hours After Breakfast Plasma Glucose (n=335,326)	-1.60 (0.241)	-1.90 (0.243)
Pre-Lunch Plasma Glucose (n=337,331)	-1.05 (0.213)	-1.23 (0.216)
2 Hours After Lunch Plasma Glucose (n=336,325)	-0.64 (0.280)	-0.63 (0.282)
Pre-Dinner Plasma Glucose (n=338,333)	-0.47 (0.261)	-0.37 (0.260)
2 Hours After Dinner Plasma Glucose (n=331,327)	-0.96 (0.298)	-1.17 (0.298)
Bedtime Plasma Glucose (n=324, 325)	-0.88 (0.324)	-0.91 (0.326)

9. Secondary Outcome

Title	Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

mITT Population. Number of participants analyzed = participants with Baseline and Month 6 basal insulin dose assessment. Missing data imputed using last observation carried forward.

Arm/Group Title	HOE901-U300	Lantus
Arm/Group Description	HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus SC injection once daily for 12 months on top of mealtime insulin.
Measure Participants	403	400
Least Squares Mean (Standard Error) [U/kg]	0.28 (0.017)	0.19 (0.017)

10. Secondary Outcome

Title	Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
Description	DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment. Missing data imputed using last observation carried forward.

Arm/Group Title	HOE901-U300	Lantus
Arm/Group Description	HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus SC injection once daily for 12 months on top of mealtime insulin.
Measure Participants	366	363
Least Squares Mean (Standard Error) [units on a scale]	2.32 (0.310)	2.24 (0.313)

11. Secondary Outcome

Title	Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12
Description	Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.

Arm/Group Title	HOE901-U300	Lantus
Arm/Group Description	HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus SC injection once daily for 12 months on top of mealtime insulin.
Measure Participants	404	402
Any Hypoglycemia Event: All Hypoglycemia	87.4 21.6%	92.0 22.8%
Severe Hypoglycemia: All Hypoglycemia	6.7 1.7%	7.5 1.9%
Documented Symptomatic: All Hypoglycemia	74.8 18.5%	82.8 20.5%
Asymptomatic: All Hypoglycemia	70.5 17.5%	73.4 18.2%
Probable Symptomatic: All Hypoglycemia	5.7 1.4%	8.5 2.1%
Relative: All Hypoglycemia	15.8 3.9%	21.1 5.2%
Severe and/or Confirmed: All Hypoglycemia	85.9 21.3%	91.5 22.7%
Any Hypoglycemia Event: Nocturnal Hypoglycemia	55.4 13.7%	66.2 16.4%
Severe Hypoglycemia: Nocturnal	2.5 0.6%	3.2 0.8%
Documented Symptomatic: Nocturnal Hypoglycemia	44.6 11%	57.2 14.2%
Asymptomatic: Nocturnal Hypoglycemia	29.2 7.2%	31.1 7.7%
Probable Symptomatic: Nocturnal Hypoglycemia	2.2 0.5%	2.7 0.7%
Relative: Nocturnal Hypoglycemia	5.0 1.2%	10.0 2.5%
Severe and/or Confirmed: Nocturnal Hypoglycemia	54.5 13.5%	64.7 16.1%

12. Other Pre-specified Outcome

Title	Change in HbA1c From Month 6 to Month 9
Description	Substudy comparing fixed dosing regimen (every 24 hours) vs. adaptive dosing regimen (every 24 +/- 3 hours) in a subset of participants randomized to HOE901-U300 and treated for 6 months.
Time Frame	Month 6 Up to Month 9

Outcome Measure Data

Analysis Population Description

mITT substudy population. Number of participants analyzed = participants with Month 6 and Month 9 HbA1c assessment. Analysis was planned to be performed for participants enrolled in the substudy and who were receiving HOE901-U300 (Adaptable dosing intervals or Fixed dosing intervals).

Arm/Group Title	HOE901-U300: Adaptable Dosing Intervals	HOE901-U300: Fixed Dosing Intervals
Arm/Group Description	HOE901-U300 SC injection once daily for 6 months on top of mealtime insulin. From Month 6 to Month 9 participants received HOE901-U300 once daily at intervals of 24 +/- 3 hours.	HOE901-U300 SC injection once daily for 6 months on top of mealtime insulin. From Month 6 up to Month 9 participants received HOE901-U300 once daily every 24 hours.
Measure Participants	55	51
Least Squares Mean (Standard Error) [percentage of hemoglobin]	0.21 (0.111)	0.15 (0.120)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HOE901-U300, Lantus
	Comments	Analysis was performed using Analysis of covariance (ANCOVA) model with treatment regimen and country as fixed effects and baseline HbA1c value as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; -0.189 to 0.298
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.123
	Estimation Comments

Adverse Events

Time Frame	All Adverse Events (AE) were collected from signature of the informed consent form up to 12 months regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description	Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of study drug up to 2 days (1 day for FPG, SMPG; 0 day for insulin glargine dose) after the last injection of study drug). Analysis was done on safety population.
Arm/Group Title	HOE901-U300		Lantus
Arm/Group Description	HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.		Lantus SC injection once daily for 12 months on top of mealtime insulin.
All Cause Mortality
	HOE901-U300		Lantus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	HOE901-U300		Lantus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	53/404 (13.1%)		62/402 (15.4%)
Blood and lymphatic system disorders
Anaemia	1/404 (0.2%)		0/402 (0%)
Cardiac disorders
Acute coronary syndrome	1/404 (0.2%)		0/402 (0%)
Angina pectoris	0/404 (0%)		2/402 (0.5%)
Angina unstable	0/404 (0%)		1/402 (0.2%)
Aortic valve stenosis	0/404 (0%)		1/402 (0.2%)
Atrial fibrillation	2/404 (0.5%)		3/402 (0.7%)
Bundle branch block left	0/404 (0%)		1/402 (0.2%)
Cardiac failure	1/404 (0.2%)		1/402 (0.2%)
Cardiac failure chronic	0/404 (0%)		1/402 (0.2%)
Cardiac failure congestive	1/404 (0.2%)		1/402 (0.2%)
Cardio-respiratory arrest	0/404 (0%)		1/402 (0.2%)
Coronary artery disease	3/404 (0.7%)		1/402 (0.2%)
Myocardial infarction	1/404 (0.2%)		1/402 (0.2%)
Myocardial ischaemia	1/404 (0.2%)		1/402 (0.2%)
Palpitations	1/404 (0.2%)		0/402 (0%)
Pulseless electrical activity	0/404 (0%)		1/402 (0.2%)
Ventricular tachycardia	1/404 (0.2%)		0/402 (0%)
Ear and labyrinth disorders
Vertigo	0/404 (0%)		1/402 (0.2%)
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic	0/404 (0%)		1/402 (0.2%)
Ileus	1/404 (0.2%)		1/402 (0.2%)
General disorders
Non-cardiac chest pain	1/404 (0.2%)		1/402 (0.2%)
Hepatobiliary disorders
Bile duct stone	1/404 (0.2%)		0/402 (0%)
Cholecystitis acute	0/404 (0%)		1/402 (0.2%)
Cholelithiasis	0/404 (0%)		1/402 (0.2%)
Immune system disorders
Anaphylactic reaction	0/404 (0%)		1/402 (0.2%)
Infections and infestations
Bronchitis	2/404 (0.5%)		0/402 (0%)
Bronchopneumonia	2/404 (0.5%)		0/402 (0%)
Cellulitis	3/404 (0.7%)		1/402 (0.2%)
Diverticulitis	0/404 (0%)		1/402 (0.2%)
Endocarditis	1/404 (0.2%)		0/402 (0%)
Erysipelas	1/404 (0.2%)		1/402 (0.2%)
Gastroenteritis	0/404 (0%)		2/402 (0.5%)
Groin abscess	1/404 (0.2%)		0/402 (0%)
Infected skin ulcer	1/404 (0.2%)		0/402 (0%)
Lyme disease	0/404 (0%)		1/402 (0.2%)
Osteomyelitis	3/404 (0.7%)		2/402 (0.5%)
Pneumonia	0/404 (0%)		3/402 (0.7%)
Pneumonia mycoplasmal	0/404 (0%)		1/402 (0.2%)
Postoperative wound infection	1/404 (0.2%)		0/402 (0%)
Pyelonephritis	0/404 (0%)		1/402 (0.2%)
Pyelonephritis acute	0/404 (0%)		1/402 (0.2%)
Sepsis	1/404 (0.2%)		1/402 (0.2%)
Septic embolus	1/404 (0.2%)		0/402 (0%)
Tracheobronchitis	0/404 (0%)		1/402 (0.2%)
Injury, poisoning and procedural complications
Abdominal wound dehiscence	1/404 (0.2%)		0/402 (0%)
Airway complication of anaesthesia	0/404 (0%)		1/402 (0.2%)
Ankle fracture	1/404 (0.2%)		0/402 (0%)
Concussion	0/404 (0%)		1/402 (0.2%)
Fall	1/404 (0.2%)		1/402 (0.2%)
Femoral neck fracture	1/404 (0.2%)		0/402 (0%)
Head injury	0/404 (0%)		1/402 (0.2%)
Humerus fracture	1/404 (0.2%)		0/402 (0%)
Meniscus injury	1/404 (0.2%)		0/402 (0%)
Procedural pain	2/404 (0.5%)		0/402 (0%)
Subdural haematoma	0/404 (0%)		1/402 (0.2%)
Tendon rupture	0/404 (0%)		1/402 (0.2%)
Toxicity to various agents	0/404 (0%)		1/402 (0.2%)
Metabolism and nutrition disorders
Diabetes mellitus inadequate control	0/404 (0%)		1/402 (0.2%)
Hyperkalaemia	0/404 (0%)		1/402 (0.2%)
Hypoglycaemia	1/404 (0.2%)		2/402 (0.5%)
Lactose intolerance	0/404 (0%)		1/402 (0.2%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/404 (0%)		1/402 (0.2%)
Arthritis	1/404 (0.2%)		0/402 (0%)
Musculoskeletal chest pain	0/404 (0%)		1/402 (0.2%)
Osteoarthritis	1/404 (0.2%)		1/402 (0.2%)
Pain in extremity	1/404 (0.2%)		0/402 (0%)
Rhabdomyolysis	2/404 (0.5%)		0/402 (0%)
Spondylitis	1/404 (0.2%)		1/402 (0.2%)
Synovial cyst	1/404 (0.2%)		1/402 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell small lymphocytic lymphoma	0/404 (0%)		1/402 (0.2%)
Basal cell carcinoma	0/404 (0%)		1/402 (0.2%)
Bladder cancer	1/404 (0.2%)		0/402 (0%)
Breast angiosarcoma	1/404 (0.2%)		0/402 (0%)
Breast cancer	2/404 (0.5%)		0/402 (0%)
Chronic myeloid leukaemia	0/404 (0%)		1/402 (0.2%)
Endometrial cancer	1/404 (0.2%)		1/402 (0.2%)
Hepatic cancer	0/404 (0%)		1/402 (0.2%)
Meningioma benign	1/404 (0.2%)		0/402 (0%)
Metastatic bronchial carcinoma	1/404 (0.2%)		0/402 (0%)
Prostate cancer	3/404 (0.7%)		1/402 (0.2%)
Squamous cell carcinoma of skin	0/404 (0%)		3/402 (0.7%)
Uterine leiomyoma	1/404 (0.2%)		0/402 (0%)
Nervous system disorders
Altered state of consciousness	0/404 (0%)		1/402 (0.2%)
Cerebral infarction	1/404 (0.2%)		0/402 (0%)
Cerebrovascular accident	0/404 (0%)		1/402 (0.2%)
Cervicobrachial syndrome	0/404 (0%)		1/402 (0.2%)
Guillain-Barre syndrome	0/404 (0%)		1/402 (0.2%)
Hypoglycaemic unconsciousness	2/404 (0.5%)		0/402 (0%)
Syncope	0/404 (0%)		1/402 (0.2%)
Transient ischaemic attack	1/404 (0.2%)		1/402 (0.2%)
Psychiatric disorders
Depression	0/404 (0%)		1/402 (0.2%)
Renal and urinary disorders
Diabetic nephropathy	0/404 (0%)		1/402 (0.2%)
Nephrolithiasis	0/404 (0%)		1/402 (0.2%)
Renal failure acute	1/404 (0.2%)		1/402 (0.2%)
Renal failure chronic	0/404 (0%)		3/402 (0.7%)
Urinary bladder polyp	1/404 (0.2%)		0/402 (0%)
Reproductive system and breast disorders
Metrorrhagia	1/404 (0.2%)		0/402 (0%)
Postmenopausal haemorrhage	1/404 (0.2%)		1/402 (0.2%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/404 (0.2%)		1/402 (0.2%)
Dyspnoea exertional	1/404 (0.2%)		0/402 (0%)
Idiopathic pulmonary fibrosis	0/404 (0%)		1/402 (0.2%)
Pulmonary embolism	1/404 (0.2%)		0/402 (0%)
Skin and subcutaneous tissue disorders
Diabetic foot	1/404 (0.2%)		1/402 (0.2%)
Skin ulcer haemorrhage	0/404 (0%)		1/402 (0.2%)
Vascular disorders
Accelerated hypertension	0/404 (0%)		1/402 (0.2%)
Aortic stenosis	0/404 (0%)		1/402 (0.2%)
Extremity necrosis	0/404 (0%)		1/402 (0.2%)
Intermittent claudication	0/404 (0%)		1/402 (0.2%)
Other (Not Including Serious) Adverse Events
	HOE901-U300		Lantus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	131/404 (32.4%)		132/402 (32.8%)
Gastrointestinal disorders
Diarrhoea	22/404 (5.4%)		21/402 (5.2%)
Infections and infestations
Bronchitis	23/404 (5.7%)		30/402 (7.5%)
Influenza	22/404 (5.4%)		18/402 (4.5%)
Nasopharyngitis	34/404 (8.4%)		36/402 (9%)
Sinusitis	21/404 (5.2%)		15/402 (3.7%)
Upper respiratory tract infection	38/404 (9.4%)		34/402 (8.5%)
Musculoskeletal and connective tissue disorders
Arthralgia	13/404 (3.2%)		21/402 (5.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.