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Completed

NCT Number: NCT02973321

A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus

Primary Objective:

The primary objective of this study was to assess the dose-response relationship of SAR425899 versus placebo in terms of glycemic control as measured by the change in glycosylated hemoglobin (HbA1c).

Secondary Objectives:

* To assess the effect of SAR425899 on body weight. * To assess the safety and immunogenicity profile of SAR425899, including assessment of the heart rate (HR) change by electrocardiogram (ECG) and Holter monitor. * To assess the proportion of participants achieving predefined HbA1c targets of <7% and <6.5% as well as the proportion of participants achieving >=5% and >=10% body weight loss. * To assess the effect of once daily dosing of SAR425899 on additional parameters of glycemic control and lipid metabolism. * To assess the effect of once daily dosing of SAR425899 on additional pharmacodynamic (PD) biomarkers. * To assess the pharmacokinetic (PK) profile and parameters of SAR425899, inter-individual and inter-occasion variability in PK parameters using a population PK approach.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site Number 1240008, Québec, Canada

Loading trial locations.

About this study

The total study duration will be approximately 30 weeks, consisting of 3 weeks screening period at the site, a 26 weeks treatment period, and 3 days post treatment follow up period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with type-2 diabetes mellitus (T2DM) for at least 3 months before the screening visit.
  • On diet/exercise and/or treatment with metformin (stable dose of ≥1500 mg/day or maximal tolerated dose) for at least 3 months prior to screening.
  • Signed informed consent.

Exclusion criteria

  • At screening, participant's age < legal age of adulthood and >80 years.
  • Glycated hemoglobin at screening visit <7.0% or >10.0%.
  • Body mass index (BMI) <25 kg/m^2 or >45.0 kg/m^2.
  • Pregnant or lactating women.
  • Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.
  • Diagnosis of type 1 diabetes mellitus.
  • Fasting plasma glucose of >15 mmol/L (270 mg/dL) measured by the central laboratory at screening (Visit 1), and confirmed (>15 mmol/L [270 mg/dL]) by a repeat test before randomization.
  • Treatment with glucose-lowering agents(s) other than metformin, currently or within the 3 months prior to screening.
  • Previous insulin use, except for episode(s) of short-term treatment (≤15 consecutive days) for intercurrent illness or pregnancy, or use of insulin within the last 6 months.
  • Contraindication(s) to metformin use.
  • Contraindication(s) to liraglutide use.
  • Significant change in body weight in the 3 months before screening.
  • Poorly controlled hypertension (a resting systolic blood pressure (SBP) >160 mm Hg and/or diastolic blood pressure (DBP) >95 mm Hg at screening).
  • History of long QT syndrome and/or QTc more than 450 ms at screening visit.
  • History of pancreatitis or pancreatectomy.
  • History of weight loss surgery.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC.
  • Any prior exposure to drugs belonging to the class of glucagon-like peptide-1 (GLP-1) receptor agonists/GLP-1 analogs.
  • Contraindications or known hypersensitivity reaction to glucagon.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Treatment and study plan

SAR425899

Drug

Self-administered by SC injection using a solution for injection in cartridge.

Placebo

Drug

Self-administered by SC injection using a solution for injection in cartridge.

liraglutide

Drug

Self-administered by SC injection using a pre-filled pen.

Other names: Victoza

metformin

Drug

Orally administered at a stable dose , >=1500 mg daily stable dose or maximal tolerated dose.

Primary outcomes

  1. Change From Baseline in HbA1c to Week 26

    Time frame: Baseline, Week 26

    Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based multiple imputation (MI) method under the missing not at random framework.

Secondary outcomes

  1. Mean Change From Baseline in Body Weight to Week 26

    Time frame: Baseline, Week 26

    Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing post- baseline values were imputed by placebo control-based MI method under the missing not at random framework.

  2. Percentage of Participants Reached HbA1c Target of <6.5% or <7% at Week 26

    Time frame: Week 26

    The analysis included assessment collected during the study, including those obtained after IMP discontinuation or introduction of rescue therapy. Participants with no measurement at Week 26 were treated as non-responders.

  3. Percentage of Participants Achieving >=5% or >=10% Body Weight Loss at Week 26

    Time frame: Week 26

    The analysis included assessment collected during the study, including those obtained after IMP discontinuation or introduction of rescue therapy. Participants with no measurement at Week 26 were treated as non-responders.

  4. Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26

    Time frame: Baseline, Week 26

    Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based MI method under the missing not at random framework.

  5. Change From Baseline in Average 7 Point Self-Monitoring Plasma Glucose (SMPG) to Week 26

    Time frame: Baseline, Week 26

    Change in 7-point SMPG profile from baseline to Week 26 was assessed by summary statistics. 7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, and Week 26): pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) is defined as 2 hours after the start of the meal.

  6. Percentage of Participants Requiring Rescue Therapy

    Time frame: Baseline up to 26 weeks

    Rescue medication was introduced in case FPG or HbA1c values were above pre-defined thresholds, and if no reasons were found for insufficient glucose control, and appropriate action failed to decrease FPG / HbA1c under the threshold values (from baseline to Week 8: FPG >270 mg/dL 15.0 mmol/L, from Week 8 to Week 14: FPG >13.3 mmol/L, and from Week 14 to Week 26: FPG >11.1 mmol/L or HbA1c>8%). The choice of rescue therapy was at the Investigator's discretion with the exception of using glucagon-like peptide-1 receptor (GLP-1R) agonists or dipeptidyl peptidase 4 (DPP4) inhibitors.

  7. Change From Baseline in Beta-Cell Function to Week 26

    Time frame: Baseline, Week 26

    Beta-cell function was assessed by homeostatic model assessment (HOMA)-beta, derived from FPG and fasting plasma insulin (FPI). HOMA-beta was derived from FPG and FPI as (20*FPI [micro units/milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated for HOMA-beta by subtracting the Baseline value from Week 26 value*100.

  8. Change From Baseline in Insulin Resistance to Week 26

    Time frame: Baseline, Week 26

    Insulin Resistance was assessed by homeostasis model assessment for insulin resistance (HOMA-IR), derived from FPG and FPI. HOMA-IR was derived from FPG and FPI as (FPI [micro units per milliliter] * FPG [mmol/L]) divided by 22.5. Change was calculated for HOMA-beta by subtracting the Baseline value from Week 26 value.

  9. Change From Baseline in Pharmacodynamic Biomarkers to Week 26 - Waist and Hip Circumferences

    Time frame: Baseline,Week 26

    Waist circumference was measured at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest, using a stretch-resistant tape providing a constant 100 gm tension. Hip circumference was measured around the widest portion of the buttocks, with the tape parallel to the floor. Each measurement was repeated twice; if the measurements were within 1 cm of one another, the average was calculated, and if the difference exceeded 1 cm, the measurements were repeated.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A 26-Week Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 25, 2016
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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