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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Biphasic insulin aspart 30; Drug: INSULIN GLARGINE (HOE901); Drug: Metformin; Drug: Insulin Glulisine; Drug: Repaglinide; Drug: Acarbose

• Registration Number: NCT03359837
• Lead Sponsor: Sanofi

Brief 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

Study Timeline

• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-30
• Study First Posted: 2017-12-02
• Study Start: 2018-01-20
• Primary Completion: 2020-06-29
• Study Completion: 2020-06-29
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 384

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glargine based therapy	Repaglinide	Once daily glargine plus prandial oral anti-hyperglycemic drugs
Premixed insulin	Biphasic insulin aspart 30	Twice daily premixed insulin
Glargine based therapy	INSULIN GLARGINE (HOE901)	Once daily glargine plus prandial oral anti-hyperglycemic drugs
Premixed insulin	Metformin	Twice daily premixed insulin
Glargine based therapy	Insulin Glulisine	Once daily glargine plus prandial oral anti-hyperglycemic drugs
Glargine based therapy	Acarbose	Once daily glargine plus prandial oral anti-hyperglycemic drugs

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin A1c (HbA1c)	Baseline to Week 24	Change in HbA1c from baseline to week 24

Secondary Outcome Measures

Name	Time	Method
Patients with fasting plasma glucose (FPG) <6.1 mmol/L	At Week 12 and Week 24	Percentage of patients with FPG \<6.1 mmol/L at week 12 and week 24
Hypoglycemic events	Baseline to Week 24	Incidence of hypoglycemia during treatment period
European quality of life - 5 dimensions (EQ-5D)	Baseline to Week 24	Change in quality of life scores from baseline to week 24 on 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is measured at 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problem.
Patients with FPG <6.1 mmol/L without hypoglycemia	At Week 12 and Week 24	Percentage of patients with FPG \<6.1 mmol/L without hypoglycemia at week 12 and week 24
Patients with HbA1c <7% without hypoglycemia	At Week 12 and Week 24	Percentage of patients with HbA1c \<7% without hypoglycemia at week 12 and week 24
Change in body weight	Baseline to Week 24	Change in body weight from baseline to week 24
Patients with FPG <7 mmol/L	At Week 12 and Week 24	Percentage of patients with FPG \<7 mmol/L at week 12 and week 2
Insulin dose	At Week 24	Total daily insulin dose at week 24
Subgroup analysis	At week 24	Subgroup analysis of control rate of HbA1c \<7% according to duration of diabetes, oral anti-hyperglycemic drug(OAD) treatment and HbA1c at screening, FPG, post prandial glucose(PPG) excursion and C peptide at the beginning of run-in period, insulin dose at end of run-in period
Patients with FPG <7 mmol/L without hypoglycemia	At Week 12 and Week 24	Percentage of patients with FPG \<7 mmol/L without hypoglycemia at week 12 and week 24
Patients with HbA1c <7%	At Week 12 and Week 24	Percentage of patients with HbA1c \<7% at week 12 and week 24
Change in FPG	Baseline to Week 24	Change in FPG from baseline to week 24
Daily BG variation at week 24	At Week 24	Daily blood glucose (BG) variation at week 24

Trial Locations

Locations (1)

CHINA; 🇨🇳 China, China