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Trial record 16 of 78 for:    sanofi-aventis and sweden

Lantus Versus Levemir Treat-To-Target (L2T3)

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ClinicalTrials.gov Identifier: NCT00405418
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : September 15, 2009
Sponsor:
Information provided by:
Sanofi

Brief Summary:

Primary objective:

To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c < 7% at the end of the treatment period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (PG) ≤ 56 mg/dL (3.1 mmol/L)

Secondary objectives:

  • To compare between the 2 treatment groups, the percentage of patients who reach the target of HbA1c < 7% and < 6.5% at the end of the treatment period
  • To compare the changes in HbA1c and fasting plasma glucose (FPG)
  • To compare the evolution of blood glucose profiles
  • To compare the day to day FPG variability, the insulin doses
  • To determine in each treatment group the biochemical and patient-related determinants of failure to reach HbA1c targets
  • To compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal symptomatic hypoglycemia confirmed by PG ≤ 56 mg/dL (3.1 mmol/L)
  • To compare over the treatment period, the overall incidence and rate of symptomatic hypoglycemia and symptomatic nocturnal hypoglycemia (with PG ≤ 70 mg/dL [3.9 mmol/L]), of symptomatic day-time hypoglycemia (with PG ≤ 70 mg/dL and with PG ≤ 56 mg/dL), of severe hypoglycemia, of asymptomatic hypoglycemia with PG ≤ 56 mg/dL
  • To compare the overall safety: incidence of adverse events (including serious hypoglycemia and local tolerance at injection site), change in body weight, in waist circumference and in waist / hip ratio
  • To assess the quality of life and treatment satisfaction

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 973 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Target Glycemic Control and the Incidence of Documented Symptomatic Hypoglycemia in Insulin naïve Subjects With Type 2 Diabetes Failing on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or Insulin Detemir.
Study Start Date : November 2006
Actual Primary Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
Experimental: 1
Insulin Glargine
Drug: Insulin glargine
Subcutaneous injection, once a day in the evening

Active Comparator: 2
Insulin Detemir
Drug: Insulin Detemir
Subcutaneous injection, twice a day at breakfast and before dinner




Primary Outcome Measures :
  1. HbA1c recorded [ Time Frame: At baseline, week 12 and week 24 ]
  2. Self-monitored fasting BG in both treatment arms and pre-dinner BG in detemir arm [ Time Frame: On the 4 consecutive days before each visit ]
  3. Self-monitored BG values from 8-point 24-hour profile recorded on 2 consecutive days [ Time Frame: Within the week prior to baseline, week 12 and week 24 ]
  4. Episodes of hypoglycemia (symptomatic, total and categorized as day-time/nocturnal, severe or asymptomatic) [ Time Frame: All across the study ]
  5. Self-monitored BG values whenever patient experiences symptoms possibly related to hypoglycemia. [ Time Frame: All across the study ]

Secondary Outcome Measures :
  1. Doses of insulin glargine or insulin detemir [ Time Frame: Daily ]
  2. Laboratory fasting plasma glucose [ Time Frame: At baseline, week 12 and week 24 ]
  3. Insulinemia and fasting C-peptide level [ Time Frame: At baseline ]
  4. Lipid profile [ Time Frame: at baseline and week 24 ]
  5. Patient reported outcomes (quality of life and treatment satisfaction) [ Time Frame: at baseline, week 4, week 12 and at the last visit ]
  6. Safety data: occurrence of adverse events and weight [ Time Frame: assessed at each visit ]
  7. Waist and hip circumferences [ Time Frame: measured at baseline, week 12 and week 24 ]
  8. Systolic and diastolic blood pressure [ Time Frame: measured at study entry, baseline, week 12 and week 24 ]
  9. Physical examination [ Time Frame: performed at study entry and at last visit. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes for at least 1 year
  • Insulin naïve
  • Treated with stable doses of oral antidiabetics for at least 3 months prior to study start, including at least metformin (at least 1g/day)
  • 7% ≤ HbA1c ≤ 10.5 %
  • Body mass index (BMI) < 40 kg/m²
  • Ability and willingness to perform blood glucose monitoring using a blood glucose meter and to use a patient diary

Exclusion Criteria:

  • Type 1 diabetes
  • Current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for less than 1 week)
  • Treatment with glucagon-like peptide (GLP)-1 receptor agonists or with dipeptidyl peptidase (DPP)-IV inhibitors
  • 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 (an optic fundus examination should have been performed in the 2 years prior to study entry)
  • Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method)
  • Breast-feeding
  • History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
  • Treatment with systemic corticosteroids in the 3 months prior to study entry
  • Treatment with any investigational product in the 2 months prior to study entry
  • 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 Alamine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal range at study entry
  • Impaired renal function as shown by serum creatinine ≥ 1.5 mg/dL (≥ 133 μmol/L) in men and ≥ 1.4 mg/dL (124 μmol/L) in women at study entry
  • History of drug or alcohol abuse in the last year

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 ClinicalTrials.gov identifier (NCT number): NCT00405418


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Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Valérie Pilorget Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00405418     History of Changes
Other Study ID Numbers: LANTU_C_00579
EUDRACT # : 2006-000324-13
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009

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