Efficacy Study on the Control of Blood Glucose Concentration in Type 1 Diabetic Patients

NCT00271284 | Completed Phase 3

• 2 other identifiers: HMR1964A_3516EudraCT #: 2005-002771-32
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

·Main objective: To compare the variability of fasting capillary blood glucose concentration, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics. It is a non-inferiority study. ·Secondary objectives: Efficacy:

• To compare the variability of blood glucose concentration before the evening meal, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics.
• To record the intra- and inter-daily variability using the MAGE and MODD indices \[1,2,3,4\]
• To compare the glycaemic profiles (7 points)
• To evaluate the HbA1c concentration, at the end of each period of treatment, weight change, the dose of insulin used and the number of daily injections. Tolerance:
• To record undesirable events
• To evaluate the safety in use from the record of episodes of hypoglycaemia (symptomatic, diurnal, nocturnal, severe).

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Efficacy data : fasting blood glucose concentration

  read daily during the last 2 months of each period

Secondary Outcomes (1)

• Tolerance data : undesirable events including episodes of hypoglycaemia

  throughout the study

Study Arms (2)

I

EXPERIMENTAL

Drug: insulin glulisine / insulin glargine

II

ACTIVE COMPARATOR

Drug: insulin glulisin / insulin detemir

Interventions

insulin glulisine / insulin glargine DRUG

insulin glargine administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00

I

insulin glulisin / insulin detemir DRUG

insulin detemir administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00

II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Belonging to a social security scheme or covered by such a scheme
• With type 1 diabetes (defined as a concentration of C-peptide \< 0.1 nmol//l and a fasting blood glucose of \>= 1.26 g/l), diagnosed not less than 5 years previously
• Treated for at least 6 months by intensive insulin treatment, following a basal-bolus system, using insulin glargine (Lantus®) as basal insulin. During the study, this insulin will administered in the evening
• Trained in the titration of prandial insulin (the dose of rapid insulin decided at each mealtime depending on the composition of the meal)
• Capable of checking their blood glucose concentration using the material supplied by the sponsor: blood glucose meter and patient notebook
• Able to eat 3 regular daily meals on the days for recording the blood glucose cycle and similarly as much as possible on other days throughout the length of the study
• Able to continue their usual daily activities during the study
• Women of child-bearing potential should be using an effective method of contraception
• Fundal examination result less than a year old available

You may not qualify if:

• Proliferating retinopathy, defined as having required treatment by surgery or photocoagulation, in the 6 months prior to visit 1, or non-stabilised (rapidly developing) retinopathy which may require photocoagulation or surgery
• Pancreatectomy
• Altered hepatic function (AST or ALT \>= 2.5 x normal, in the initial measurements)
• Altered renal function (plasma creatinine \> 1.5 mg/dl)
• Acute infection
• Acute or chronic metabolic acidosis
• Gastroparesis
• History of cancer in the last 5 years
• Medically significant cardiovascular, hepatic, neurological or endocrine disease or any other significant disease making carrying out the protocol or interpreting the trial results difficult
• History of drug or alcohol abuse
• Subject likely to receive treatment during the trial which is not authorised in the protocol (see Section 6.2), in particular, treatment by corticosteroids whatever the route of administration or dose.
• Antidiabetic treatment by products other than those supplied within the framework of this study
• Hypersensitivity to one of the study products (insulin glargine, insulin detemir, insulin glulisine) or to one of the excipients present in the insulin preparations, used in the study
• Working at night
• Pregnancy

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Paris, France

Location

Related Publications (1)

• Renard E, Dubois-Laforgue D, Guerci B; Variability Study Group. Non-inferiority of insulin glargine versus insulin detemir on blood glucose variability in type 1 diabetes patients: a multicenter, randomized, crossover study. Diabetes Technol Ther. 2011 Dec;13(12):1213-8. doi: 10.1089/dia.2011.0063. Epub 2011 Aug 2.

  PMID: 21810024 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin glulisine; Insulin Glargine; Insulin Detemir

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Marie SEBILLE, Dr

  Sanofi

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 29, 2005
• First Posted: December 30, 2005
• Study Start: October 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

FR (1)