Insulin Glulisine in Diabetes Mellitus, Type 2 (GINGER)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00174668
First received: September 9, 2005
Last updated: September 14, 2009
Last verified: September 2009
  Purpose

Primary objective:

The primary study objective is to demonstrate superior efficacy of an intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of change in glycated hemoglobin A1c (HbA1c), from baseline to endpoint.

Secondary objectives:

Secondary study objectives are to compare the intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of blood glucose (BG) values (fasting, pre-/postprandial (ppBG), nocturnal, mean daily, fasting plasma glucose), daily BG profiles, BG and HbA1c response rates (predefined), hypoglycemic events, adverse events, change of late diabetes complications, weight, body-mass-index, course of total daily insulin dose and adjustment, blood lipid profile, microalbuminuria, standard lab and quality of life/treatment satisfaction.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin Glulisine
Drug: Insulin Therapy
Drug: Insulin Glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 52-week, Open, Randomized, Multinational, Multicenter Clinical Trial Comparing Insulin Glulisine in Combination With Insulin Glargine in an Intensified Insulin Regimen to a Two-injection Conventional Insulin Regimen in Type 2 Diabetes Mellitus Patients With Poor Glycemic Control Pretreated With a Two-injection Conventional Insulin Therapy

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • HbA1c [ Time Frame: From baseline to study endpoint ] [ Designated as safety issue: No ]
  • Self monitored BG (SMBG) values [ Time Frame: During the whole treatment phase ] [ Designated as safety issue: No ]
  • Body weight/body mass index (BMI) [ Time Frame: From baseline to study endpoint and all other visits ] [ Designated as safety issue: No ]
  • Fasting blood lipid profile [ Time Frame: From baseline to study endpoint and all other visits ] [ Designated as safety issue: No ]
  • Urine albumin [ Time Frame: From baseline to study endpoint and all other visits ] [ Designated as safety issue: No ]
  • Total daily insulin dose [ Time Frame: From baseline to study endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Throughout the study, ] [ Designated as safety issue: Yes ]
  • Standard laboratory tests [ Time Frame: From baseline to study endpoint and all other visits ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: From baseline to study endpoint and all other visits ] [ Designated as safety issue: No ]
  • Physical examination [ Time Frame: From baseline to study endpoint and all other visits ] [ Designated as safety issue: No ]

Enrollment: 311
Study Start Date: November 2004
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Mealtime insulin glulisine 3x daily and insulin glargine 1 x daily subcutaneously
Drug: Insulin Glulisine
insulin glulisine 3 x daily (TID) subcutaneously 15 min before the start of a meal
Drug: Insulin Glargine
1 x daily (OD) subcutaneously at any time (but every day at the same time) according to BG
Active Comparator: 2
Two daily injection conventional insulin therapy
Drug: Insulin Therapy
NPH (70%) plus regular insulin or insulin aspart (30%)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

Subjects meeting all of the following criteria will be considered for enrollment into the study:

  • Type 2 diabetes mellitus, as defined by the American Diabetes Association for at least five years, treated with insulin for at least 6 months (no history of ketoacidosis).
  • HbA1c between 7.5% and 11.0%, inclusive at both pre-screening and pre-randomization (week -2).
  • For at least 3 months prior to week -8 visit, subjects must have been on a stable insulin regimen with two daily s.c. injections of premixed insulin: NPH plus regular insulin or NPH plus rapid acting insulin (insulin lispro or insulin aspart) in a mixture of 70/30 or 75/25. "Stable" means no change in regimen and no more than 30 % change in dose. Optionally, the subject can have been treated in addition with metformin according to its current official product information leaflet, treatment with other oral blood glucose lowering drugs is not allowed.
  • Documentation of a full ophthalmologic exam (incl. fundoscopy)during the 6 months prior to randomization.
  • Women are either not of childbearing potential (surgically sterile, or postmenopausal for more than 2 years). Women of childbearing potential must not be pregnant and agree to use a reliable contraceptive measure for the duration of the study. Reliable contraceptive measures include the following: systemic contraceptive (oral, implant, injections), diaphragm with intravaginal spermicide, cervical cap, intrauterine device or condom with spermicide.
  • Willing and able to perform specified home blood glucose monitoring and to otherwise comply with study protocol requirements.
  • Willing to change from a twice daily insulin regimen to a regimen requiring four daily insulin injections.
  • Provision of signed and dated informed consent prior to any study procedures."Prescreening" informed consent, obtained in writing for all subjects, may be used during screening, but full study-specific informed consent must be obtained in writing for all subjects after any post-screening procedures.

Exclusion criteria :

Subjects presenting with any of the following will not be included in the study:

  • Two or more severe hypoglycemic episodes within the past 3 months, or any hospitalization or emergency room visit due to poor diabetic control within the past 3 months prior to randomization.
  • History of hypoglycemia unawareness.
  • Impaired hepatic function, as shown by, but not limited to, ALAT (SGPT) or ASAT (SGOT) above 2x the upper limit of normal as measured at visit 1.
  • Impaired renal function, as shown by, but not limited to, serum creatinine > 177 mmol/l (> 2 mg/dl) as measured at visit 1 (if no lower values due to individual metformin intake are required) or current renal dialysis.
  • Body mass index (BMI) > 38 kg/m2.
  • Any other clinically significant abnormalities on screening laboratory evaluation (unless discussed with the monitor and approved by the study management).
  • Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation) during the study.
  • History of hypersensitivity to insulin or insulin analogues or any of the excipients in the HMR 1964 formulation.
  • Donation of blood or transfusion during the 2 months prior to the screening visit.
  • Pregnant or lactating women, or women planning to become pregnant during the study.
  • Treatment with any investigational drug in the last month before visit 1 (screening).
  • Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
  • Any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, hematologic or other major systemic diseases making implementation of the protocol or interpretation of the study results difficult.
  • Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.
  • History of drug or alcohol abuse within the last 2 years or current addiction to substances of abuse.
  • Night shift workers.
  • Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
  • Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174668

Locations
Australia
Sanofi-Aventis
North Ryde, Australia
Belgium
Sanofi-Aventis
Brussels, Belgium
Czech Republic
Sanofi-Aventis
Prague, Czech Republic
France
Sanofi-Aventis
Paris, France
Germany
Sanofi-Aventis
Berlin, Germany
Italy
Sanofi-Aventis
Milan, Italy
Netherlands
Sanofi-Aventis
Gouda, Netherlands
Poland
Sanofi-Aventis
Warsaw, Poland
Portugal
Sanofi-Aventis
Porto Salvo, Portugal
Romania
Sanofi-aventis
Bucharest, Romania
Slovakia
Sanofi-Aventis
Bratislava, Slovakia
Spain
Sanofi-Aventis
Barcelona, Spain
Sweden
Sanofi-Aventis
Stockholm, Sweden
Switzerland
Sanofi-Aventis
Meyrin, Switzerland
United Kingdom
Sanofi-Aventis
Guildford, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Valérie Pilorget, MD Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00174668     History of Changes
Other Study ID Numbers: HMR1964A_3504, EUDRACT # : 2004-001287-49
Study First Received: September 9, 2005
Last Updated: September 14, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Insulin glulisine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014