NCT02836704 is a Phase 4 clinical trial of INSULIN GLARGINE in Diabetes Mellitus, Type 2, sponsored by Sanofi.

Who is sponsoring NCT02836704?

NCT02836704 is sponsored by Sanofi.

What drugs are being tested in NCT02836704?

Interventions in NCT02836704: INSULIN GLARGINE, metformin, acarbose.

What condition does NCT02836704 study?

NCT02836704 studies Diabetes Mellitus, Type 2.

Is NCT02836704 still recruiting?

NCT02836704 is currently completed. Last updated 25 April 2022.

Last reviewed 2022-04-25 · How we verify

NCT02836704

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)

Completed Phase 4 Last updated 25 April 2022

What this trial tests

Phase 4 trial testing INSULIN GLARGINE in Diabetes Mellitus, Type 2 in 892 participants. Completed in 26 April 2018.

Timeline

9 September 2016

Primary endpoint
26 April 2018

26 April 2018

Quick facts

Lead sponsor	Sanofi
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	892
Start date	9 September 2016
Primary completion	26 April 2018
Estimated completion	26 April 2018
Sites	1 location across China

Drugs / interventions tested

INSULIN GLARGINE (INSULIN GLARGINE) — full drug profile →
metformin (metformin) — full drug profile →
acarbose (ACARBOSE) — full drug profile →

Conditions studied

Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Sanofi — full company profile →

Who can join

Adults 18 to 70, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary Objective: -To test the hypothesis that higher initial dose of basal insulin (0.3 U/kg) is non inferior to standard initial dose (0.2 U/kg) based on the percentage of patients with at least one episode of hypoglycemia (≤3.9 mmol/L or severe) during the 16 weeks of treatment in overweight and obese type 2 diabetic patients uncontrolled with oral anti-diabetes drugs (OADs). Secondary Objective: * To evaluate the percentage of patients achieving glycated hemoglobin (HbA1c) \<7%. * To evaluate the percentage and accumulated percentage of patients achieving fasting plasma glucose (FPG) target (\<5.6, \<6.1, and \<7.0 mmol/L). * To assess the changes in HbA1c, FPG, and postprandial glucose (PPG). * To evaluate the insulin doses change. * To evaluate the weight change. * To evaluate overall hypoglycemia, nocturnal hypoglycemia and severe hypoglycemia occurrence. * To descriptively evaluate the safety profile. * To assess patient and physician satisfaction and adherence (drop-out rate and the percentage of patients who can follow the treatment and insulin titration). * Subgroup analysis on efficacy (control rate, control rate without confirmed hypoglycemia, and changes in HbA1c, FPG and PPG) and safety data according to: * Age * Duration of diabetes * Baseline treatment (OAD) * Baseline HbA1c, FPG and PP

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of INSULIN GLARGINE

Trials testing the same drug.

NCT02606357 — Treatment of Type 2 Diabetes With Long Acting Basal Insulin in Jordan · Phase 4 · completed
NCT02545842 — Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BE · Phase 4 · completed

Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 · Phase 2 · recruiting
NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting

Other Sanofi trials

Trials by the same sponsor.

NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02836704 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi
Last refreshed: 25 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02836704.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing