Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)

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Sanofi

Status and phase

Completed
Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Insulin Glulisine (HMR1964)
Drug: Metformin
Drug: INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)
Drug: INSULIN GLARGINE (HOE901)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03529123
INSLIL08556
U1111-1200-1162 (Other Identifier)

Details and patient eligibility

About

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.

Full description

The maximum study duration per patient is 33 weeks.

Enrollment

247 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

247 participants in 2 patient groups

Tested Drug
Experimental group
Description:
Insulin glargine/lixisenatide fixed ratio combination (FRC)
Treatment:
Drug: Insulin Glulisine (HMR1964)
Drug: Metformin
Drug: INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)
Control Drug
Active Comparator group
Description:
Insulin glargine (Lantus®)
Treatment:
Drug: INSULIN GLARGINE (HOE901)
Drug: Insulin Glulisine (HMR1964)
Drug: Metformin

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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