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Trial record 15 of 63 for:    Lixisenatide

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)

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ClinicalTrials.gov Identifier: NCT02941367
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
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.

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

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Actual Study Start Date : February 23, 2017
Actual Primary Completion Date : August 4, 2017
Actual Study Completion Date : August 4, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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





Primary Outcome Measures :
  1. 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 :
  1. Mean change in HbA1c [ Time Frame: Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan ]
  2. Mean change in body weight [ Time Frame: Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan ]
  3. Percentage of patients with 2-hour post prandial glucose (2hPPG) <180 mg/dL (10 mmol/L) [ Time Frame: Last 14 days of Ramadan month ]
  4. Percentage of patients with HbA1C <7% [ Time Frame: At 0-4 weeks pre- and 0-4 weeks post-Ramadan ]
  5. Percentage of patients with fasting plasma glucose (FPG) <130 mg/dL (7.22 mmol/L) [ Time Frame: At pre-Ramadan visit ]
  6. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941367


Locations
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India
Investigational Site Number 356005
Ahmedabad, India, 380007
Investigational Site Number 356002
Bangalore, India, 560043
Investigational Site Number 356015
Bangalore, India, 560055
Investigational Site Number 356008
Bangalore, India, 560060
Investigational Site Number 356009
Hyderabad, India, 500001
Investigational Site Number 356018
Hyderabad, India, 500004
Investigational Site Number 356010
Hyderabad, India, 500072
Investigational Site Number 356003
Hyderabad, India, 500095
Investigational Site Number 356007
Jaipur, India
Investigational Site Number 356019
Madurai, India, 625020
Investigational Site Number 356014
Mumbai, India, 400007
Investigational Site Number 356022
Nagpur, India, 440010
Israel
Investigational Site Number 376001
Haifa, Israel, 31096
Investigational Site Number 376002
Safed, Israel, 13100
Kuwait
Investigational Site Number 414001
Kuwait, Kuwait
Turkey
Investigational Site Number 792002
Zonguldak, Turkey
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02941367     History of Changes
Other Study ID Numbers: LPS14410
U1111-1172-3026 ( Other Identifier: UTN )
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lixisenatide
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs