Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: PREMIXED INSULIN; Drug: INSULIN GLARGINE; Drug: INSULIN GLULISINE

• Registration Number: NCT01121835
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To demonstrate the superiority of a strategy with insulin glargine in comparison with a strategy including the premixed insulin in term of percentage of patients reaching HbA1c (glycosylated hemoglobin) below 7% at the end of treatment and who do not experience documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) below 56 mg/dL (3.1 mmol/L)) over a 24-week treatment period, in Type 2 diabetes patients failing lifestyle management and oral agents.

Secondary Objectives:

To assess the effect of insulin glargine in comparison with premixed insulin on :

* Evolution of HbA1c level during the treatment period Percentage of patients who reach the target of HbA1c \< 7 % and who do not experience documented symptomatic hypoglycemia confirmed by a Plasma Glucose (PG) below 70 mg/dL (3.9 mmol/L)

* Percentage of patients who reach the target of HbA1c \< 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 56 mg/dL (3.1 mmol/L) \>Percentage of patients who reach the target of HbA1c \< 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 70 mg/dL (3.9 mmol/L) \>Evolution of Fasting Plasma Glucose Evolution of 7-point plasma glucose profiles

* Evolution of weight

* Hypoglycemia occurrence

* Dose of insulins

* Evolution of liver function

* Overall safety

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-11
• Study First Posted: 2010-05-12
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-02
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 934

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin glargine	INSULIN GLULISINE	Administered once a day in the evening, at the same time every day. The starting daily dose is 0.2 U/Kg of body weight or 12 U, at the investigator's decision. Insulin glulisine is administered for patients of the insulin glargine group requiring insulin glulisine at week 12 (visit 11). Insulin glulisine is administered prior (10-15 min) to the main meal of the day, which is the meal with highest Post-Prandial Plasma Glucose (PPPG) on the 3 profiles performed before week 12. Starting dose is of 4 units per day.
Premixed insulin	PREMIXED INSULIN	administered once a day (in the evening at dinner) or twice a day (in the morning before breakfast and in the evening at dinner). Starting daily dose will be 6 U at breakfast and 6 U at dinner, if administered twice a day or 12 U at dinner if administered once a day
Insulin glargine	INSULIN GLARGINE	Administered once a day in the evening, at the same time every day. The starting daily dose is 0.2 U/Kg of body weight or 12 U, at the investigator's decision. Insulin glulisine is administered for patients of the insulin glargine group requiring insulin glulisine at week 12 (visit 11). Insulin glulisine is administered prior (10-15 min) to the main meal of the day, which is the meal with highest Post-Prandial Plasma Glucose (PPPG) on the 3 profiles performed before week 12. Starting dose is of 4 units per day.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) ≤ 56 mg/dL [3.1 mmol/L]	From baseline (visit 2, week 0) to visit 14 (week 24)

Secondary Outcome Measures

Name	Time	Method
Self-monitored PG (Plasma Glucose) values over 3 consecutive days	before visit 12 (week 16)
7-point plasma glucose (PG) profile recorded on 3 consecutive days	From baseline (visit 2, week 0) to visit 14 (week 24)
Insulin doses of the day before each visit	from visit 3 (week 1) to visit 14 (week 24)
Weight and supine blood pressure	From baseline (visit 2, week 0) to visit 14 (week 24)
Biochemistry and lipid profile	From baseline (visit 2, week 0) to visit 14 (week 24)

Trial Locations

Locations (96)

Investigational Site Number 040-004; 🇦🇹 Sankt Stefan, Austria

Investigational Site Number 040-002; 🇦🇹 Vienna, Austria

Investigational Site Number 040-001; 🇦🇹 Vienna, Austria

Investigational Site Number 040-003; 🇦🇹 Vienna, Austria

Investigational Site Number 076002; 🇧🇷 Belém, Brazil

Investigational Site Number 076005; 🇧🇷 Curitiba, Brazil

Investigational Site Number 076004; 🇧🇷 Fortaleza, Brazil

Investigational Site Number 076001; 🇧🇷 Porto Alegre, Brazil

Investigational Site Number 076003; 🇧🇷 São Paulo, Brazil

Investigational Site Number 156004; 🇨🇳 Beijing, China

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