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Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy

NCT03359837 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2022-04-25

No results posted yet for this study

Summary

Primary Objective:

To test the hypothesis that basal insulin based treatment (G+) is noninferior to twice-daily premixed insulin (PM-2) in term of hemoglobin A1c (glycosylated hemoglobin, HbA1c) reduction from baseline to end of study. The test for superiority can be done if noninferiority is achieved.

Secondary Objectives:

* To assess efficacy in terms of percentage of patients achieving HbA1c \<7% and HbA1c \<7% without hypoglycemia.
* To assess efficacy in terms of percentage of patients achieving fasting plasma glucose (FPG) \<7 mmol/L and FPG \<7 mmol/L without hypoglycemia.
* To assess safety in term of occurrence of moderate/severe hypoglycemia.
* To assess daily blood glucose (BG) variation.
* To assess patient satisfaction.

Conditions

Interventions

DRUG

INSULIN GLARGINE (HOE901)

Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

DRUG

Insulin Glulisine

Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

DRUG

Biphasic insulin aspart 30

Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

DRUG

Repaglinide

Pharmaceutical form: tablet Route of administration: oral administration

DRUG

Acarbose

Pharmaceutical form: tablet Route of administration: oral administration

DRUG

Metformin

Pharmaceutical form: tablet 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
2018-01-20
Primary Completion
2020-06-29
Completion
2020-06-29

Countries

  • China

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Entities

Drugs
Diseases
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 NCT03359837 on ClinicalTrials.gov