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Trial record 2 of 10 for:    lixisenatide | Open Studies

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 (LixiRam)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT02941367
First received: October 12, 2016
Last updated: April 19, 2017
Last verified: April 2017
  Purpose

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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Lixisenatide (AVE0010)
Drug: Sulfonylurea
Drug: metformin
Drug: basal insulin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: International, Randomized, Open Label Study to Compare the Safety and Efficacy of Lixisenatide vs. Sulfonylurea on Top of Basal Insulin Treatment in Type 2 Diabetes Mellitus Subjects Who Elect to Fast During Ramadan

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 236
Actual Study Start Date: February 23, 2017
Estimated Study Completion Date: September 30, 2017
Estimated Primary Completion Date: September 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lyxumia
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.
Drug: Lixisenatide (AVE0010)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Name: Lyxumia
Drug: metformin

Pharmaceutical form: tablet

Route of administration: oral

Drug: basal insulin

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Active Comparator: 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.
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


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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02941367

Contacts
Contact: For site information, send an email with site number to 800-981-2491 Contact-Us@sanofi.com

Locations
Israel
Investigational Site Number 376001 Recruiting
Haifa, Israel, 31096
Investigational Site Number 376002 Recruiting
Safed, Israel, 13100
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02941367     History of Changes
Other Study ID Numbers: LPS14410
U1111-1172-3026 ( Other Identifier: UTN )
Study First Received: October 12, 2016
Last Updated: April 19, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017