Phase 2
Completed N=296
A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02973321 ↗Enrolled (actual)
296
Serious AEs
3.4%
Results posted
Feb 2021
Primary outcomePrimary: Change From Baseline in HbA1c to Week 26 — -0.663; -1.517; -1.618; -1.562 percentage of HbA1c — p=< 0.0001
Summary
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 =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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c to Week 26 |
-0.663; -1.517; -1.618; -1.562; -1.312 | < 0.0001 sig |
| SECONDARY Mean Change From Baseline in Body Weight to Week 26 |
-1.759; -4.276; -5.330; -4.407; -4.590 | 0.0012 sig |
| SECONDARY Percentage of Participants Reached HbA1c Target of <6.5% or <7% at Week 26 |
12.1; 47.0; 51.5; 48.4; 44.8; 36.4 | — |
| SECONDARY Percentage of Participants Achieving >=5% or >=10% Body Weight Loss at Week 26 |
3.0; 33.3; 45.5; 35.9; 40.3; 0.0 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26 |
-0.931; -2.408; -2.548; -2.318; -2.124 | — |
| SECONDARY Change From Baseline in Average 7 Point Self-Monitoring Plasma Glucose (SMPG) to Week 26 |
-1.82; -2.86; -2.63; -2.49; -2.21 | — |
| SECONDARY Percentage of Participants Requiring Rescue Therapy |
18.2; 0.0; 1.5; 3.1; 6.0 | — |
| SECONDARY Change From Baseline in Beta-Cell Function to Week 26 |
15.025; 26.768; 31.122; 17.932; 27.263 | — |
| SECONDARY Change From Baseline in Insulin Resistance to Week 26 |
-1.315; -1.244; -2.233; -2.324; -1.405 | — |
| SECONDARY Change From Baseline in Pharmacodynamic Biomarkers to Week 26 - Waist and Hip Circumferences |
-2.0; -5.3; -2.3; -3.2; -4.0; -1.42 | — |
Eligibility Criteria
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 80 years.
- Glycated hemoglobin at screening visit 10.0%.
- Body mass index (BMI) 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.
Data sourced from ClinicalTrials.gov (NCT02973321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.