Current partner codePEPTIDESDE
NCT02941367·Phase 4·INTERVENTIONAL

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

Status

Completed

Phase

Phase 4

Enrollment

184

Locations

16

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

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.

Full 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).

Interventions

Treatment arms and agents.

DRUG

Lixisenatide (AVE0010)

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

Sulfonylurea

Pharmaceutical form: tablet Route of administration: oral

DRUG

metformin

Pharmaceutical form: tablet Route of administration: oral

DRUG

basal insulin

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Timeline

From registration to results.

  1. First posted

    Oct 21, 2016

  2. Study start

    Feb 23, 2017

  3. Primary completion

    Aug 4, 2017

  4. Study completion

    Aug 4, 2017

  5. Results posted

    Not reported

  6. Registry updated

    Apr 25, 2022

Outcomes

What the study measures.

Primary outcomes

Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L)

Time frame · Approximately 30 days (from start to end of Ramadan holy month)

Secondary outcomes

Mean change in HbA1c

Time frame · Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan

Mean change in body weight

Time frame · Baseline, 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)

Time frame · Last 14 days of Ramadan month

Percentage of patients with HbA1C <7%

Time frame · 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)

Time frame · At pre-Ramadan visit

Percentage of patients with HbA1c <7%, no weight gain and no documented symptomatic hypoglycemia (plasma glucose ≤70 mg/dL; 3.9 mmol/L)

Time frame · At 0-4 weeks pre- and 0-4 weeks post-Ramadan

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion criteria : * Patients with type 2 diabetes mellitus, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with basal insulin + SU (≤50% max allowed dose) ±1 oral antidiabetic (OAD) drug. * Patients who express the intention to fast during Ramadan. * Signed informed consent. Exclusion criteria: * At the time of screening age \< legal age of majority. * Glycated hemoglobin (HbA1c) at screening visit: \<7.5% or \>10%. * Body mass index (BMI) \<20kg/m\^2. * Treatment with basal insulin for less than 6 months prior to screening. * Prior antidiabetic medication (basal insulin and OADs) not at stable dose (eg, same medication, frequency and \<20% dose change) in the last 8 weeks prior to screening. * Previous treatment with short or rapid acting insulin other than for short term use (≤10 days) in relation to hospitalization or an acute illness in the last 6 months prior to screening. * Any discontinuation from a glucagon like peptide-1 receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy. * Patient not willing to perform self-monitored plasma glucose (SMPG) as required by protocol and to follow the instructions provided. * Type 1, gestational or secondary diabetes. * History of diabetic ketoacidosis. * History of hypoglycemia unawareness. * Any medical contraindication for sustained and safe fasting. * Pregnant or breast-feeding women. * Women of childbearing potential (WOCB) not protected by highly effective contraceptive method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy. * Known hypersensitivity/intolerance to lixisenatide (Lyxumia) or any of its excipients. * All contraindications of the comparator and protocol mandated background therapies or warning/precaution of use (when appropriate) as displayed in the respective National Product Labeling. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study locations

16 registered sites.

India · Israel · Kuwait · Turkey (Türkiye). Showing up to 24 locations stored in the fast local snapshot.

Investigational Site Number 356005

Ahmedabad, India

Investigational Site Number 356002

Bangalore, India

Investigational Site Number 356015

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 356003

Hyderabad, India

Investigational Site Number 356007

Jaipur, India

Investigational Site Number 356019

Madurai, India

Investigational Site Number 356014

Mumbai, India

Investigational Site Number 356022

Nagpur, India

Investigational Site Number 376001

Haifa, Israel

Investigational Site Number 376002

Safed, Israel

Investigational Site Number 414001

Kuwait City, Kuwait

Investigational Site Number 792002

Zonguldak, Turkey (Türkiye)

Related trials

More studies on Lixisenatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.