Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Lixisenatide (AVE0010); Drug: Sulfonylurea; Drug: metformin; Drug: basal insulin

• Registration Number: NCT02941367
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To compare the safety, in terms of percentage of patients with symptomatic documented hypoglycemia during Ramadan fast, of lixisenatide versus sulfonylurea (SU).

Secondary Objectives:

* To assess effect of lixisenatide versus SU on:

* Changes in glycemic control;

* Changes in body weight.

* To assess overall safety of lixisenatide and SU.

Detailed Description

The total study duration per patient will have a minimum 12 weeks and maximum 22 weeks (up to 2 weeks screening period + 8-12 weeks pre-Ramadan period + 29-30 days Ramadan + 0 4 weeks post-Ramadan period). This is a phase 3b study in Kingdom of Saudi Arabia and Bangladesh (instead of phase 4 for other countries).

Study Timeline

• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-20
• Study First Posted: 2016-10-21
• Study Start: 2017-02-23
• Primary Completion: 2017-08-04
• Study Completion: 2017-08-04
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lyxumia	Lixisenatide (AVE0010)	Patients will receive Lyxumia once daily as investigational medicinal product (IMP) on top of patient's previous basal insulin with/without metformin. Non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment.
Lyxumia	basal insulin	Patients will receive Lyxumia once daily as investigational medicinal product (IMP) on top of patient's previous basal insulin with/without metformin. Non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment.
Sulfonylurea	Sulfonylurea	Patients will continue the treatment with previous Sulfonylurea as IMP on top of patient's previous basal insulin with/without metformin. The IMP and non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment.
Sulfonylurea	basal insulin	Patients will continue the treatment with previous Sulfonylurea as IMP on top of patient's previous basal insulin with/without metformin. The IMP and non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment.
Sulfonylurea	metformin	Patients will continue the treatment with previous Sulfonylurea as IMP on top of patient's previous basal insulin with/without metformin. The IMP and non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment.
Lyxumia	metformin	Patients will receive Lyxumia once daily as investigational medicinal product (IMP) on top of patient's previous basal insulin with/without metformin. Non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L)	Approximately 30 days (from start to end of Ramadan holy month)

Secondary Outcome Measures

Name	Time	Method
Mean change in HbA1c	Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan
Percentage of patients with HbA1c <7%, no weight gain and no documented symptomatic hypoglycemia (plasma glucose ≤70 mg/dL; 3.9 mmol/L)	At 0-4 weeks pre- and 0-4 weeks post-Ramadan
Percentage of patients with 2-hour post prandial glucose (2hPPG) <180 mg/dL (10 mmol/L)	Last 14 days of Ramadan month
Mean change in body weight	Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan
Percentage of patients with HbA1C <7%	At 0-4 weeks pre- and 0-4 weeks post-Ramadan
Percentage of patients with fasting plasma glucose (FPG) <130 mg/dL (7.22 mmol/L)	At pre-Ramadan visit

Trial Locations

Locations (16)

Investigational Site Number 356005; 🇮🇳 Ahmedabad, India

Investigational Site Number 356002; 🇮🇳 Bangalore, India

Investigational Site Number 356008; 🇮🇳 Bangalore, India

Investigational Site Number 356009; 🇮🇳 Hyderabad, India

Investigational Site Number 356018; 🇮🇳 Hyderabad, India

Investigational Site Number 356010; 🇮🇳 Hyderabad, India

Investigational Site Number 356022; 🇮🇳 Nagpur, India

Investigational Site Number 376002; 🇮🇱 Safed, Israel

Investigational Site Number 414001; 🇰🇼 Kuwait, Kuwait

Investigational Site Number 792002; 🇹🇷 Zonguldak, Turkey

Investigational Site Number 356014; 🇮🇳 Mumbai, India

Investigational Site Number 376001; 🇮🇱 Haifa, Israel

Investigational Site Number 356019; 🇮🇳 Madurai, India

Investigational Site Number 356003; 🇮🇳 Hyderabad, India

Investigational Site Number 356015; 🇮🇳 Bangalore, India

Investigational Site Number 356007; 🇮🇳 Jaipur, India