NCT00174642

Brief Summary

Primary objectives :

  • To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin combined with 3 bolus of insulin glulisine (Arm 1), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs.
  • To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin and insulin secretagogue (sulfonylurea or glinide) combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 3), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs. Secondary objectives :
  • To compare between the 3 treatment groups: evolution of HbA1c over time, percentage of subjects with HbA1c \<= 7% at the end of the study, evolution of blood glucose profiles, incidence of hypoglycemia, insulin doses, evolution of body weight and treatment satisfaction.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
811

participants targeted

Target at P75+ for phase_3 diabetes-mellitus-type-2

Geographic Reach
18 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

Enrollment Period

4 years

First QC Date

September 9, 2005

Last Update Submit

September 14, 2009

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (5)

  • HbA1c

    From the beginning to the end of the study

  • 24-hour blood glucose levels

    From the beginning to the end of the study

  • symptomatic hypoglycemia (diurnal and nocturnal)

    From the beginning to the end of the study

  • Severe hypoglycemia (diurnal and nocturnal),

    From the beginning to the end of the study

  • Insulin doses

    From the beginning to the end of the study

Secondary Outcomes (2)

  • Vital signs

    From the beginning to the end of the study

  • Adverse events

    From the beginning to the end of the study

Study Arms (3)

1

EXPERIMENTAL

Insulin Glargine + 3 bolus of Insulin Glulisine + Metformin

Drug: Insulin GlargineDrug: Insulin GlulisineDrug: Metformin

2

EXPERIMENTAL

Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin

Drug: Insulin GlargineDrug: Insulin GlulisineDrug: Metformin

3

EXPERIMENTAL

Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin + Insulin secretagogue

Drug: Insulin GlargineDrug: Insulin GlulisineDrug: MetforminDrug: insulin secretagogue

Interventions

Insulin GlargineDRUG

One daily injection in the evening. 100 U/ml

123
Insulin GlulisineDRUG

Given immediately before each of the three main meals. 100 U/ml

123
MetforminDRUG

At same dosages as the previous treatment

123
insulin secretagogueDRUG

sulfonylurea or glinide

3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetic
  • BMI ≤ 40 kg/m²
  • HbA1c \> 7%
  • Treated with basal insulin (NPH, Insulin Zinc, insulin glargine or insulin detemir), and at least, two OAD including an insulin secretagogue (sulfonylurea or glinide, at any dosage) and metformin (at the maximum tolerated dosage), for more than 6 months

You may not qualify if:

  • Type 1 diabetes mellitus
  • Treatment with OADs only
  • Treatment with thiazolidinediones
  • Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
  • Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (confirmed by an optic fundus performed in the 2 years prior study entry)
  • Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)
  • Breast-feeding
  • History of hypersensitivity to the study drug or to drugs with a similar chemical structure or to insulin glargine
  • Treatment with systemic corticosteroids, irrespective of the dose of administration and irrespective of the prior or foreseeable treatment duration
  • Treatment with any investigational product in the last 2 months before study entry, except for insulin glargine
  • Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
  • Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
  • Impaired hepatic function as shown by ALT and/or AST greater than three times the upper limit of normal at study entry
  • Impaired renal function as shown by serum creatinine \>135 μmol/l in men and \> 110 μmol/l in women at study entry
  • History of drug or alcohol abuse
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Sanofi-Aventis

Brussels, Belgium

Location

Sanofi-Aventis

Paris, France

Location

Sanofi-Aventis

Berlin, Germany

Location

Sanofi-Aventis

Athens, Greece

Location

Sanofi-Aventis

Budapest, Hungary

Location

Sanofi-Aventis

Dublin, Ireland

Location

Sanofi-Aventis

Milan, Italy

Location

Sanofi-Aventis

Vilnius, Lithuania

Location

Sanofi-Aventis

México, Mexico

Location

Sanofi-Aventis

Gouda, Netherlands

Location

Sanofi-Aventis

Warsaw, Poland

Location

Sanofi-Aventis

Moscow, Russia

Location

Sanofi-Aventis

Seoul, South Korea

Location

Sanofi-Aventis

Barcelona, Spain

Location

Sanofi-Aventis

Stockholm, Sweden

Location

Sanofi-Aventis

Taipei, Taiwan

Location

Sanofi-Aventis

Istanbul, Turkey (Türkiye)

Location

Sanofi-Aventis

Guildford, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargineinsulin glulisineMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Valérie Pilorget, MD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

December 1, 2004

Primary Completion

December 1, 2008

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

TU(1)BE(1)FR(1)IT(1)GR(1)HU(1)LI(1)ME(1)RU(1)TW(1)GB(1)SE(1)ES(1)PL(1)DE(1)NL(1)IE(1)KR(1)