Efficacy and Safety of Insuman Basal/Comb/Rapid in Patients With Type 2 Diabetes

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: insulin human (HR1799)

• Registration Number: NCT01630369
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

- To evaluate the decrease of Hb A1c ≥ 1% after 6 month treatment in patients with Type 2 Diabetes Mellitus (T2DM) uncontrolled on Oral Antidiabetics (OADs)

Secondary Objectives:

* To evaluate the percentage of patients with Hb A1c \< 7.5%,

* To evaluate the rate of hypoglycaemia (symptomatic, severe)

* To evaluate the middle dose of insulin per product - Insuman Basal, Insuman Comb, Insuman Rapid after 6 month treatment

* To evaluate the change in Fasting Plasma Glucose (FPG) after 6 month treatment

* To assess the overall safety

* To evaluate the efficacy of education courses in Diabetes Schools (% of correct answers after second test compare to the testing of the initial level)

Detailed Description

6 months

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-28
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-16
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 552

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Human Insulin	insulin human (HR1799)	Dosage of human insulin (Insuman Basal/Comb/Rapid) will be individually adjusted in accordance with the Summary of Product Characteristics (SmPC). Patients will follow the titration algorithm recommended by the physician.

Primary Outcome Measures

Name	Time	Method
Decrease of Hb A1c ≥ 1%	Baseline, 6 months

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with Hb A1c < 7.5%	6 months
Rate of hypoglycaemias (symptomatic, severe)	6 months
Middle dose of insulin per product (Insuman Basal, Insuman Comb, Insuman Rapid)	6 months
Change in FPG	Baseline 6 months
Number of patients with adverse events	6 months
Assessment of efficacy of education courses in Diabetes Schools	Baseline, 6 months	Percentage of correct answers after second test compare to the testing of the initial level

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇺🇦 Kyiv, Ukraine