NCT03359837

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

A 26-Week, Multi-Center, Open-label, Randomized, Parallel-group Study to Evaluate the Efficacy and Safety of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-Term Intensive Insulin Therapy: Basal Insulin Based Treatment (With Prandial OADs Combination) Versus Twice-daily Premixed Insulin

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The duration of study is approximately 21 months. Each patient will be followed for approximately 27 weeks from screening visit to end-of-study

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-01-20
• Primary completion: 2020-06-29
• Completion: 2020-06-29
• First posted: 2017-12-02
• Last updated: 2022-04-25

Locations

1 site across 1 country: China