Primary Objective: * To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus Secondary Objective: * To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal hypoglycemia
The maximum study duration was up to approximately 58 weeks per participants, 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
811
Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).
HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s). 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.
Change in HbA1c From Baseline to Month 6 Endpoint
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time frame: Baseline, Month 6
Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint
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 mmol/L (70 milligram per deciliter \[mg/dL\]). Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time frame: Week 9 Up to Month 6
Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint
Preinjection 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. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time frame: Baseline, Month 6
Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint
Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of co-efficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time frame: Baseline, Month 6
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Investigational Site Number 840517
Birmingham, Alabama, United States
Investigational Site Number 840149
Chandler, Arizona, United States
Investigational Site Number 840093
Glendale, Arizona, United States
Investigational Site Number 840069
Phoenix, Arizona, United States
Investigational Site Number 840110
Sun City, Arizona, United States
Investigational Site Number 840068
Tempe, Arizona, United States
Investigational Site Number 840015
Hot Springs, Arkansas, United States
Investigational Site Number 840014
Little Rock, Arkansas, United States
Investigational Site Number 840114
Little Rock, Arkansas, United States
Investigational Site Number 840018
Mountain Home, Arkansas, United States
...and 203 more locations
Percentage of Participants With HbA1c <7% at Month 6 Endpoint
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time frame: Month 6
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time frame: Baseline, Month 6
Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time frame: Month 6
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint
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. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time frame: Baseline, Month 6
Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time frame: Baseline, Month 6
Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
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. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Time frame: Baseline, Month 6
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline 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).
Time frame: Up to Month 12