Type 2 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine by demonstrating change in glycosylated hemoglobin (HbA1c). Secondary Objectives: * To assess the effects of the FRC in comparison with insulin glargine on: * Percentage of patients reaching HbA1c targets (\<7% ); * Glycemic control in relation to a meal as evaluated by 2-hour Post-prandial Plasma Glucose; (PPG); * Body weight * Fasting Plasma Glucose (FPG); * Percentage of patients reaching HbA1c targets of \<7% with no body weight gain and no hypoglycemia (as defined in the evaluation criteria); * 7-point Self-Monitoring Plasma Glucose (SMPG) profile; * Insulin glargine dose. * To assess the safety and tolerability in each treatment group.
Detailed description
The maximum study duration per patient is 33 weeks.
Interventions
Pharmaceutical form: Injection Route of administration: Subcutaneous
Pharmaceutical form: Injection Route of administration: Subcutaneous
DRUGMetformin
Pharmaceutical form: Tablet Route of administration: Oral
Pharmaceutical form: Injection Route of administration: Subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
: * Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit, * At screening: * Age should be ≥ 18 years of age to \< 65 years; * Glycosylated hemoglobin (HbA1c) at screening visit ≥ 7.5% or ≤ 10%; * Body mass index (BMI) ≥ 19 kg/m2 and ≤ 40 kg/m2. * Patients who have been treated with a basal insulin for at least 6 months before the screening visit, and who have been on a stable basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before the screening visit. The stable total daily dose should be within the range of 15-40 U, both inclusive, on the day of screening, but individual fluctuations of ± 20% within 2 months prior to screening are acceptable.
Exclusion criteria
* Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria in the 3 months before screening. * Previous use of insulin regimen other than basal insulin eg, prandial or pre-mixed insulin (Note: Short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator). * For patients taking metformin, any contraindication to metformin use, according to local labeling. * For patient not treated with metformin at screening: severe renal function impairment with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 or end-stage renal disease. * Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes). * Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie, worsening) or not controlled (ie, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening visit; or history of surgery affecting gastric emptying. * History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy. * Average insulin glargine daily dose \<20 U or \>50 U calculated for the last 3 days before Visit 6. * Amylase and/or lipase \>3 upper limit normal (ULN) at Visit 5 (Week -1). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | From baseline to Week 24 | Mean change in glycosylated hemoglobin (HbA1c) from baseline to Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 2-hour Post prandial glucose (PPG) | From baseline to Week 24 | Change in 2-hour PPG from baseline to Week 24 |
| Change in body weight | From baseline to Week 24 | Change in body weight from baseline to Week 24 |
| Patients with HbA1c <7% with no body weight gain and no hypoglycemia | At Week 24 | Number of patients reaching HbA1c \<7% with no body weight gain and no hypoglycemia at the end of Week 24 |
| Patients with HbA1c <7% | At Week 24 | Number of patients reaching HbA1c \<7 % at the end of Week 24 |
| Adverse events (AE) | Up to 33 weeks | Number of AEs |
| Patients with HbA1c <7% with no body weight gain | At Week 24 | Number of patients reaching HbA1c \<7% with no body weight gain at the end of Week 24 |
| Change in SMPG profiles | From baseline to Week 24 | Change in 7-point self-monitoring plasma glucose (SMPG) profiles from baseline to Week 24 |
| Change in Fasting Plasma Glucose | From baseline to Week 24 | Mean change in FPG from baseline to Week 24 |
Countries
India
Outcome results
None listed