AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 2NCT02973321

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

A Phase 2 study testing SAR425899, Liraglutide and Metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 59 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
SAR425899, Liraglutide and Metformin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
296 participants
Where
59 sitesin 8 countries
Study dates
2 Dec 2016to 27 Dec 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

59 sites in 8 countries.

59 sites in 8 countries

United States23 sites

  • Investigational Site Number 8400004

    Austin, Texas, 78731

  • Investigational Site Number 8400013

    Chicago, Illinois, 60827

  • Investigational Site Number 8400006

    Dallas, Texas, 75230

  • Investigational Site Number 8400027

    Denver, Colorado, 80209

  • Investigational Site Number 8400005

    Fargo, North Dakota, 58103

  • Investigational Site Number 8400014

    Flint, Michigan, 48532-3447

  • Investigational Site Number 8400021

    Houston, Texas, 77079

  • Investigational Site Number 8400002

    Huntington Park, California, 90255

  • Investigational Site Number 8400020

    Linden, New Jersey, 07036

  • Investigational Site Number 8400024

    Los Angeles, California, 90017

  • Investigational Site Number 8400001

    Los Angeles, California, 90057

  • Investigational Site Number 8400025

    Miami, Florida, 33166

  • Investigational Site Number 8400018

    New Orleans, Louisiana, 70119

  • Investigational Site Number 8400022

    New York, New York, 10001

  • Investigational Site Number 8400007

    Palm Harbor, Florida, 34684

  • Investigational Site Number 8400012

    Port Hueneme, California, 93041

  • Investigational Site Number 8400019

    Rockville, Maryland, 20852

  • Investigational Site Number 8400026

    San Antonio, Texas, 78229

  • Investigational Site Number 8400028

    Sheffield, Alabama, 35660

  • Investigational Site Number 8400017

    Sugar Land, Texas, 77478

  • Investigational Site Number 8400003

    Troy, Michigan, 48085

  • Investigational Site Number 8400016

    Wichita, Kansas, 67205

  • Investigational Site Number 8400023

    Wichita, Kansas, 67207

Other trials in United States

Spain8 sites

  • Investigational Site Number 7240001

    A Coruña, 15006

  • Investigational Site Number 7240005

    Barcelona, 08035

  • Investigational Site Number 7240007

    Ferrol, 15405

  • Investigational Site Number 7240006

    Las Palmas de Gran Canaria, 35016

  • Investigational Site Number 7240002

    Madrid, 28040

  • Investigational Site Number 7240003

    Málaga, 29010

  • Investigational Site Number 7240004

    Málaga, 29010

  • Investigational Site Number 7240008

    Seville, 41071

Other trials in Spain

Hungary6 sites

  • Investigational Site Number 3480001

    Balatonfüred, 8230

  • Investigational Site Number 3480002

    Budapest, 1027

  • Investigational Site Number 3480008

    Budapest, 1042

  • Investigational Site Number 3480005

    Budapest, 1062

  • Investigational Site Number 3480006

    Budapest, 1062

  • Investigational Site Number 3480007

    Budapest, 1213

Other trials in Hungary

Canada5 sites

  • Investigational Site Number 1240008

    Québec, G1S 2L6

  • Investigational Site Number 1240005

    Sainte-Foy, G1W4R4

  • Investigational Site Number 1240002

    Sherbrooke, J1L 0H8

  • Investigational Site Number 1240001

    Toronto, M4G 3E8

  • Investigational Site Number 1240003

    Vancouver, V5Y 3W2

Other trials in Canada

Mexico5 sites

  • Investigational Site Number 4840004

    Actopan, 42500

  • Investigational Site Number 4840001

    Guadalajara, 44600

  • Investigational Site Number 4840003

    Guadalajara, 44670

  • Investigational Site Number 4840002

    Monterrey, 64460

  • Investigational Site Number 4840006

    San Juan del Río, 76800

Other trials in Mexico

Russia5 sites

  • Investigational Site Number 6430002

    Saint Petersburg, 190068

  • Investigational Site Number 6430004

    Saint Petersburg, 194358

  • Investigational Site Number 6430001

    Saint Petersburg, 195257

  • Investigational Site Number 6430003

    Saratov, 410030

  • Investigational Site Number 6430005

    Voronezh, 394018

Other trials in Russia

Czechia4 sites

  • Investigational Site Number 2030003

    České Budějovice, 370 01

  • Investigational Site Number 2030001

    Krnov, 79401

  • Investigational Site Number 2030004

    Praha 10 - Uhrineves, 104 00

  • Investigational Site Number 2030002

    Praha 9 - Klanovice, 19014

Other trials in Czechia

Germany3 sites

  • Investigational Site Number 2760003

    Berlin, 10115

  • Investigational Site Number 2760001

    Dresden, 01307

  • Investigational Site Number 2760006

    Hohenmölsen, 06679

Other trials in Germany

About this study

Official 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

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).

Read more

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.
Read the detailed description

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.

Being tested
SAR425899, Placebo, Liraglutide, Metformin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR425899Drug

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

  • PlaceboDrug

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

  • LiraglutideDrug

    Also called Victoza

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

  • MetforminDrug

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

Study groups in NCT02973321
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo (for SAR425899) subcutaneous (SC) injection once daily (QD) from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
Receives: Drug: Placebo; Drug: Metformin
SAR425899 0.12 mgExperimentalSAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
Receives: Drug: SAR425899; Drug: Metformin
SAR425899 0.16 mgExperimentalSAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
Receives: Drug: SAR425899; Drug: Metformin
SAR425899 0.20 mgExperimentalSAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
Receives: Drug: SAR425899; Drug: Metformin
LiraglutideActive comparatorLiraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
Receives: Drug: Liraglutide; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in HbA1c to 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.

    Measured: Baseline, Week 26

Secondary outcomes (9)

  1. Mean Change From Baseline in Body Weight to 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.

    Measured: Baseline, Week 26

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

    Measured: Week 26

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

    Measured: Week 26

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

    Measured: Baseline, Week 26

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

    Measured: Baseline, Week 26

  6. Percentage of Participants Requiring Rescue Therapy

    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.

    Measured: Baseline up to 26 weeks

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

    Measured: Baseline, Week 26

  8. Change From Baseline in Insulin Resistance to 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.

    Measured: Baseline, Week 26

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

    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.

    Measured: Baseline,Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2016 (estimated)
  2. Study start2 Dec 2016
  3. Primary completion27 Dec 2017
  4. Study completion27 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
296 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02973321
Sponsor's protocol ID
DRI13940
Other IDs
2016-001328-77, U1111-1179-4786, 2016
Status last verified
Mar 2022
First submitted
22 Nov 2016
Last updated
24 Mar 2022
Data monitoring committee
Yes
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Schiavon M, Visentin R, Gobel B, Riz M, Cobelli C, Klabunde T, Dalla Man C. Improved postprandial glucose metabolism in type 2 diabetes by the dual glucagon-like peptide-1/glucagon receptor agonist SAR425899 in comparison with liraglutide. Diabetes Obes Metab. 2021 Aug;23(8):1795-1805. doi: 10.1111/dom.14394. Epub 2021 May 5.

    PubMed 33822469

  • Gater A, Reaney M, Findley A, Brun-Strang C, Burrows K, Nguyen-Pascal ML, Roborel de Climens A. Development and First Use of the Patient's Qualitative Assessment of Treatment (PQAT) Questionnaire in Type 2 Diabetes Mellitus to Explore Individualised Benefit-Harm of Drugs Received During Clinical Studies. Drug Saf. 2020 Feb;43(2):119-134. doi: 10.1007/s40264-019-00877-4.

    PubMed 31679129

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAR425899, Liraglutide and Metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 59 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Spain, Hungary, Canada, Mexico and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c to Week 26 (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02973321, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in