Insulin Glargine in Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00311818
Recruitment Status : Completed
First Posted : April 6, 2006
Last Update Posted : September 15, 2009
Information provided by:

Brief Summary:

Primary objective:

  • To compare efficacy of oral antidiabetics (OAD) combination therapy with either HOE901 insulin analogue once daily or Lispro insulin analogue at mealtime in terms of change in HbA1c (baseline to endpoint).

Secondary objectives:

  • To compare the OAD combination therapy with either HOE901 insulin analogue once daily or Lispro insulin analogue at mealtime in terms of efficacy and safety.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Insulin glargine Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 44-week, Parallel, Open, Randomized, Multinational, Multi-center Clinical Trial to Compare Efficacy and Safety of the Combination Therapy of an Oral Anti-diabetic Drug Treatment With Either HOE901 Insulin Once Daily or Lispro Insulin Analogue at Mealtime in Type 2 Diabetes Mellitus Patients Poorly Controlled With Oral Anti-diabetic Drug Treatment.
Study Start Date : June 2003
Actual Primary Completion Date : May 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Frequency of subjects with HbA1c: ≤ 6.5 %, 6.5 %< HbA1c ≤ 7.0 %, 7.0 %<HbA1c ≤ 8.0 % and HbA1c > 8.0 % [ Time Frame: at endpoint ]

Secondary Outcome Measures :
  1. Change in fasting blood glucose, (FBG) [ Time Frame: baseline to endpoint ]
  2. Frequency of subjects with: FBG ≤ 100 mg/dl (5.5 mmol/l), 100 mg/dl < FBG ≤ 126 mg/dl(7.0 mmol/l) and FBG > 126 mg/dl (7.0 mmol/l) [ Time Frame: at endpoint ]
  3. Change in nocturnal blood glucose [ Time Frame: baseline to endpoint ]
  4. Change in fasting plasma glucose [ Time Frame: baseline to endpoint and all visits ]
  5. Change in mean daytime blood glucose [ Time Frame: baseline to endpoint ]
  6. Change in mean daily blood glucose [ Time Frame: baseline to endpoint ]
  7. Change in blood glucose at the remaining time points of the 8-point-blood glucose profiles [ Time Frame: baseline to endpoint ]
  8. Frequency of subjects with hypoglycemic events (overall, severe, nocturnal, symptomatic) [ Time Frame: from the inform consent signature to the end of the study ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with Type 2 Diabetes mellitus for at least 1 year (no history of ketoacidosis) and treatment with oral antidiabetics (OAD) for at least 6 months prior to study entry
  • Subjects poorly controlled with previous OAD treatment: any mono or combination therapy approved in combination with insulin according to local SPCs (summary of product characteristics), not including use of alpha-glucosidase inhibitors, at a stable dose for least 3 month prior to study entry
  • Poor metabolic control with HbA1c (glycosylated hemoglobin) values between 7.5 % and 10.5 % and FBG > or = 120 mg/dl (6.6 mmol/l)
  • Body mass index < or = 35 kg/m2
  • Ability and willingness of a tight antidiabetic therapy under a stable life-style with regular meals and to perform blood glucose self monitoring and especially blood glucose profiles using a blood glucose meter at home, as evidence by daily FBG measurements and a complete 8-point blood glucose profile obtained over a 24-hour period

Exclusion Criteria:

  • Treatment with any insulin in the last 4 weeks prior to study entry
  • Diabetes mellitus following pancreatectomy
  • GAD positive (glutamic acid decarboxylase)
  • Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the 3 months prior to study entry or which may require surgical treatment within 3 months of study entry
  • Pregnant or breast-feeding
  • Women of childbearing potential who did not take adequate contraceptive protection such as systemic hormones (birth control pills, implant), intrauterine device, or a barrier method (diaphragm with intravaginal spermicidal, cervical cap, male or female condom)
  • History of hypersensitivity to the study medication or to drugs with similar chemical structures
  • Treatment with any investigational drug in the last 3 months before study entry
  • Previous enrollment in a study involving HOE901 insulin analogue
  • Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g. non-cardio selective beta-blockers, systemic corticosteroids)
  • Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, hematological or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
  • History of drug or alcohol abuse
  • Impaired hepatic function, as shown by, but not limited to,alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) above 3x the upper limit of normal, if no lower values are required by the individually administered OAD
  • Impaired renal function, as shown by, but not limited to, serum creatinine > 177 mmol/l (> 2 mg/dl), if no lower values are required by the individually administered OAD

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00311818

Sponsors and Collaborators
Study Director: Valérie Pilorget Sanofi

Publications of Results:
Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00311818     History of Changes
Other Study ID Numbers: HOE901_4040
First Posted: April 6, 2006    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009

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