MedTrace Logo

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

NCT02836704 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 892

Last updated 2022-04-25

No results posted yet for this study

Summary

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

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

INSULIN GLARGINE

Pharmaceutical form: solution Route of administration: subcutaneous injection

DRUG

metformin

Pharmaceutical form: table or capsule Route of administration: oral administration

DRUG

acarbose

Pharmaceutical form: table or capsule Route of administration: oral administration

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-09
Primary Completion
2018-04-26
Completion
2018-04-26

Countries

  • China

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02836704 on ClinicalTrials.gov