baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: INSULIN GLARGINE; Drug: INSULIN GLULISINE

• Registration Number: NCT01204593
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day, tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Type 1 Diabetes Mellitus (T1DM).

Secondary Objectives:

To evaluate:

* The change of hemoglobin A1c (HbA1c) from baseline to week 12

* The percentage of patients with HbA1c \< 7% at week 12 and week 24

* The FBG and the 7-point self monitoring of blood glucose (SMBG) at baseline, week 12 and week 24

* The daily dose for both insulin glulisine insulin glargine at baseline, week 12 and week 24

* The incidence of symptomatic hypoglycemias

* Adverse events

Detailed Description

After a two-week run-in period patients will enter a six-month treatment period.

Estimated study duration per patient : 26 weeks (including a 2-week run-in period).

Study Timeline

• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-16
• Study First Posted: 2010-09-17
• Study Start: 2010-11
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-14
• Last Update Posted: 2014-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insulin glargine + insulin glulisine	INSULIN GLARGINE	Insulin glargine dosage will be individually titrated once a week to obtain FPG 80-120 mg/dL (4.5-6.7 mmol/L). Insulin glulisine dosage will be individually titrated once a week to obtain a 2-hour postprandial plasma glucose (PPG) \< 180 mg/dL (\<10.0 mmol/L) and ideally around 140 mg/dL.
Insulin glargine + insulin glulisine	INSULIN GLULISINE	Insulin glargine dosage will be individually titrated once a week to obtain FPG 80-120 mg/dL (4.5-6.7 mmol/L). Insulin glulisine dosage will be individually titrated once a week to obtain a 2-hour postprandial plasma glucose (PPG) \< 180 mg/dL (\<10.0 mmol/L) and ideally around 140 mg/dL.

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin A1c (HbA1c) values (following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC))	between baseline (week 0) and endpoint (week 24)

Secondary Outcome Measures

Name	Time	Method
Change of HbA1c	from baseline to week 12
Percentage of patients with HbA1c < 7%	at week 12 and week 24
Fasting Blood Glucose (FBG)	at baseline, week 12 and week 24
7-point Self Monitoring of Blood Glucose (SMBG)	at baseline, week 12 and week 24 (to be performed the week preceding each visit on two consecutive days)
Daily dose for insulin glulisine	At baseline, week 12 and week 24
Daily dose for insulin glargine	At baseline, week 12 and week 24
Symptomatic hypoglycemias	From baseline (week 0) to endpoint (week 24)

Trial Locations

Locations (43)

Investigational Site Number 01202; 🇩🇿 Algiers, Algeria

Investigational Site Number 03201; 🇦🇷 Caba, Argentina

Investigational Site Number 12468; 🇿🇦 Benoni, South Africa

Investigational Site Number 12484; 🇿🇦 Port Elizabeth, South Africa

Investigational Site Number 78801; 🇹🇳 Sfax, Tunisia

Investigational Site Number 710005; 🇿🇦 Pretoria, South Africa

Investigational Site Number 076-003; 🇧🇷 Distrito Federal, Brazil

Investigational Site Number 076-006; 🇧🇷 Marília, Brazil

Investigational Site Number 076-010; 🇧🇷 Fortaleza, Brazil

Investigational Site Number 076-004; 🇧🇷 Porto Alegre, Brazil

Investigational Site Number 076-002; 🇧🇷 São Paulo, Brazil

Investigational Site Number 03204; 🇦🇷 Caba, Argentina

Investigational Site Number 076-007; 🇧🇷 Curitiba, Brazil

Investigational Site Number 17003; 🇨🇴 Barranquilla, Colombia

Investigational Site Number 17004; 🇨🇴 Bogotá, Colombia

Investigational Site Number 17005; 🇨🇴 Bogotá, Colombia

Investigational Site Number 17007; 🇨🇴 Bogotá, Colombia

Investigational Site Number 01; 🇰🇼 Kuwait, Kuwait

Investigational Site Number 17006; 🇨🇴 Medellin, Colombia

Investigational Site Number 48401; 🇲🇽 Guadalajara, Mexico

Investigational Site Number 48404; 🇲🇽 Guadalajara, Mexico

Investigational Site Number 1; 🇸🇦 Riyadh, Saudi Arabia

Investigational Site Number 12464; 🇿🇦 Durban, South Africa

Investigational Site Number 710004; 🇿🇦 Benoni, South Africa

Investigational Site Number 12466; 🇿🇦 Bloemfontein, South Africa

Investigational Site Number 710006; 🇿🇦 Bloemfontein, South Africa

Investigational Site Number 710001; 🇿🇦 Durban, South Africa

Investigational Site Number 12465; 🇿🇦 Durban, South Africa

Investigational Site Number 710002; 🇿🇦 Durban, South Africa

Investigational Site Number 710003; 🇿🇦 Port Elizabeth, South Africa

Investigational Site Number 12467; 🇿🇦 Pretoria, South Africa

Investigational Site Number 78802; 🇹🇳 Tunis, Tunisia

Investigational Site Number 78805; 🇹🇳 Sfax, Tunisia

Investigational Site Number 78804; 🇹🇳 Tunis, Tunisia

Investigational Site Number 78803; 🇹🇳 Tunis, Tunisia

Investigational Site Number 01203; 🇩🇿 Algiers, Algeria

Investigational Site Number 03202; 🇦🇷 Caba, Argentina

Investigational Site Number 01201; 🇩🇿 Algeries, Algeria

Investigational Site Number 01204; 🇩🇿 Algiers, Algeria

Investigational Site Number 03203; 🇦🇷 Caba, Argentina

Investigational Site Number 03205; 🇦🇷 Morón, Argentina

Investigational Site Number 48402; 🇲🇽 Guadalajara, Mexico

Investigational Site Number 48403; 🇲🇽 Monterrey, Mexico