Efficacy and Safety of the Insulin Glargine or Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes

Phase 3

Completed

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2018/05/013853
• Lead Sponsor: Sanofi Synthelabo India Private Limited

Brief Summary

This study is a randomized, open label, parallel group, multi-center trial comparing the efficacy and safety of Insulin Glargine and Lixisenatide Fixed Ratio Combination to Insulin Glargine, for 24 weeks in 254 patients with Type 2 Diabetes Patients that will be conducted in fifteen centers in India.  The primary objective is to demonstrate the superiority of the insulin glargine and lixisenatide fixed ratio combination FRC to insulin glargine by demonstrating change in glycosylated hemoglobin HbA1c over 24 weeks. The secondary objectives is to assess the effects of FRC in comparison with Insulin Glargine over 24 weeks for following parameters HBA1C, 2 Hour Post Prandial Glucose, Fasting Plasma Glucose, Weight Gain, Hypoglycemic events and 7-Point Self-Monitoring Plasma Glucose.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-19
• Study Completion: 2019-11-25
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

• 1 Patients with type 2 diabetes mellitus or T2DM diagnosed for at least 1 year before the screening visit 2 At screening Age should be greater or equal to 18 years of age to less than 65 years HbA1c at screening visitgreater or equal to 7.5 percent or less than or equal to 10 percent BMI greater than or equal to 19 kg per m2 and less than or equal to 40 kg per m2 3 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 or 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 plus or minus 20 percent within 2 months prior to screening are acceptable 4 For patients receiving basal insulin AND 1 or 2 oral anti-diabetic drugs or OADs the OAD doses must be stable during the 3 months before the screening visit.
• The OADs can be 1 to 2 out of a metformin less than or equal to 1000mg per day or maximal tolerated dose a sulfonylurea or SU a glinide • a dipeptidyl peptidase 4 inhibitor or DPP 4 inhibitor or a AGI a thiazolidinedione 5 FPG less than or equals to 180 mg per dL at screening visit for patients receiving basal insulin in combination with 2 OADs or with 1 OAD other than metformin FPG les tan or equals to 200 mg per dL at screening visit for patients on basal insulin only or basal insulin plus metformin at screening visit Note A second FPG test may be repeated between 5 to 15 days of the first FPG test to confirm the above FPG value.
• 6 Signed written informed consent.
• Inclusion criteria for randomization at the end of the run-in period 7 HbA1c greater than or equal to 7 percent or les than or equal to 10 percent at visit 5 Week 1 8 Mean fasting SMPG is less tan or equal to 140 mg per dL calculated from all available minimum of 4 self-measurements values during the 7 days prior to randomization visit V6 Note: fasting SMPG on the day of randomization can be included if assessed before randomization.

Exclusion Criteria

• 1 Pregnancy or lactation 2 Women of childbearing potential not protected by highly effective contraceptive method of birth control 3 Use of oral or injectable glucose lowering agents other than those stated in the inclusion criteria in the 3 months before screening 4 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 5 History of discontinuation of a previous treatment with Glucagon Like Peptide 1 GLP 1 receptor agonist for safety or tolerability reasons or lack of efficacy 6 Laboratory findings at the screening visit, including Amylase and or lipase less than 3 times the upper limit of the normal ULN laboratory range, ALT or AST less than 3 ULN Calcitonin greater or less than 20 pg per mL pmolper L Positive serum pregnancy test 7 For patients taking metformin, any contraindication to metformin use, according to local labeling 8 For patient not treated with metformin at screening: severe renal function impairment with an estimated glomerular filtration rate eGFR less than 30 mLper minper 1.73m2 or end stage renal disease 9 History of allergic reaction to any GLP 1 receptor agonist in the past or to metacresol 10 Contraindication to use of insulin glargine according to local labeling.
• 11 History of hypersensitivity to insulin glargine or to any of the excipients 12 Personal or immediate family history of medullary thyroid cancer MTC or genetic condition that predisposes to MTC eg, multiple endocrine neoplasia syndromes 13 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.
• 14 History of pancreatitis unless pancreatitis was related to gallstones and cholecystectomy has been performed, pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.
• 15 Average insulin glargine daily dose less than 20 U or greater than 50 U calculated for the last 3 days before Visit 6 15 Amylase and or or lipase less than 3 ULN at Visit 5 Week 1.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in HbA1c from baseline to week 24 in the 2 arms	Baseline to week 24

Secondary Outcome Measures

Name	Time	Method
1 Percentage of patients reaching HbA1c less than 7 percent at the end of week 24	2 Change in 2 hour PPG 2 hours after breakfast from baseline to week 24.

Trial Locations

Locations (13)

AIIMS Hospital; 🇮🇳 South, DELHI, India

Arthur Asirvatham Hospital; 🇮🇳 Madurai, TAMIL NADU, India

CIMET’s Inamdar Multispecialty Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Department of Clinical Research Max Cure Hospitals; 🇮🇳 RoadHyderabad, India

Dr Ram Manohar Lohia Institute of Medical Sciences; 🇮🇳 Lucknow, UTTAR PRADESH, India

Eternal Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Fortis Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

KLEs Dr Prabhakar Kore Hospital and Medical Research Centre; 🇮🇳 Belgaum, KARNATAKA, India

Kovai Diabetes Speciality Centre & Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

Lifecare Clinic & Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

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AIIMS Hospital

🇮🇳South, DELHI, India

Dr Rajesh Khadgawat

Principal investigator

919891418190

rajeshkhadgawat@hotmail.com