Lantus Versus Levemir Treat-To-Target - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00405418

Purpose

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	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Insulin glargine Drug: Insulin Detemir	Phase IV

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Insulin Insulin glargine Insulin Detemir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

HbA1c recorded [ Time Frame: At baseline, week 12 and week 24 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Episodes of hypoglycemia (symptomatic, total and categorized as day-time/nocturnal, severe or asymptomatic) [ Time Frame: All across the study ] [ Designated as safety issue: No ]
Self-monitored BG values whenever patient experiences symptoms possibly related to hypoglycemia. [ Time Frame: All across the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Doses of insulin glargine or insulin detemir [ Time Frame: Daily ] [ Designated as safety issue: No ]
Laboratory fasting plasma glucose [ Time Frame: At baseline, week 12 and week 24 ] [ Designated as safety issue: No ]
Insulinemia and fasting C-peptide level [ Time Frame: At baseline ] [ Designated as safety issue: No ]
Lipid profile [ Time Frame: at baseline and week 24 ] [ Designated as safety issue: No ]
Patient reported outcomes (quality of life and treatment satisfaction) [ Time Frame: at baseline, week 4, week 12 and at the last visit ] [ Designated as safety issue: No ]
Safety data: occurrence of adverse events and weight [ Time Frame: assessed at each visit ] [ Designated as safety issue: Yes ]
Waist and hip circumferences [ Time Frame: measured at baseline, week 12 and week 24 ] [ Designated as safety issue: No ]
Systolic and diastolic blood pressure [ Time Frame: measured at study entry, baseline, week 12 and week 24 ] [ Designated as safety issue: No ]
Physical examination [ Time Frame: performed at study entry and at last visit. ] [ Designated as safety issue: No ]

Enrollment:	973
Study Start Date:	November 2006
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Insulin Glargine	Drug: Insulin glargine Subcutaneous injection, once a day in the evening
2: Active Comparator Insulin Detemir	Drug: Insulin Detemir Subcutaneous injection, twice a day at breakfast and before dinner

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405418

Show 20 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Valérie Pilorget

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	LANTU_C_00579, EUDRACT # : 2006-000324-13
Study First Received:	November 29, 2006
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00405418
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009