Lantus Versus Levemir Treat-To-Target

Diabetes Mellitus, Type 2 Clinical Trial

— L2T3  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405418
• Other study ID #: LANTU_C_00579
• Secondary ID: EUDRACT # : 2006
• Status: Completed
• Phase: Phase 4
• First received: November 29, 2006
• Last updated: September 14, 2009
• Start date: November 2006

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 973
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin glargine
Subcutaneous injection, once a day in the evening
• Insulin Detemir
Subcutaneous injection, twice a day at breakfast and before dinner

Locations

Country	Name	City	State
Australia	Sanofi-Aventis	North Ryde
Brazil	Sanofi-Aventis	Sao Paolo
Canada	Sanofi-Aventis	Laval
Denmark	Sanofi-Aventis	Hoersholm
Finland	Sanofi-Aventis	Helsinki
Germany	Sanofi-Aventis	Berlin
India	Sanofi-Aventis	Mumbai
Ireland	Sanofi-Aventis	Dublin
Korea, Republic of	Sanofi-Aventis	Seoul
Netherlands	Sanofi-Aventis	Gouda
Portugal	Sanofi-Aventis	Porto Salvo
Romania	Sanofi-Aventis	Bucharest
Russian Federation	Sanofi-Aventis	Moscow
Serbia	Sanofi-Aventis	Belgrade
Spain	Sanofi-Aventis	Barcelona
Sweden	Sanofi-Aventis	Stockholm
Switzerland	Sanofi-Aventis	Meyrin
Taiwan	Sanofi-Aventis	Taipe
Turkey	Sanofi-Aventis	Istanbul
United Kingdom	Sanofi-Aventis	Guildford

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Australia,  Brazil,  Canada,  Denmark,  Finland,  Germany,  India,  Ireland,  Korea, Republic of,  Netherlands,  Portugal,  Romania,  Russian Federation,  Serbia,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c recorded		At baseline, week 12 and week 24	No
Primary	Self-monitored fasting BG in both treatment arms and pre-dinner BG in detemir arm		On the 4 consecutive days before each visit	No
Primary	Self-monitored BG values from 8-point 24-hour profile recorded on 2 consecutive days		Within the week prior to baseline, week 12 and week 24	No
Primary	Episodes of hypoglycemia (symptomatic, total and categorized as day-time/nocturnal, severe or asymptomatic)		All across the study	No
Primary	Self-monitored BG values whenever patient experiences symptoms possibly related to hypoglycemia.		All across the study	No
Secondary	Doses of insulin glargine or insulin detemir		Daily	No
Secondary	Laboratory fasting plasma glucose		At baseline, week 12 and week 24	No
Secondary	Insulinemia and fasting C-peptide level		At baseline	No
Secondary	Lipid profile		at baseline and week 24	No
Secondary	Patient reported outcomes (quality of life and treatment satisfaction)		at baseline, week 4, week 12 and at the last visit	No
Secondary	Safety data: occurrence of adverse events and weight		assessed at each visit	Yes
Secondary	Waist and hip circumferences		measured at baseline, week 12 and week 24	No
Secondary	Systolic and diastolic blood pressure		measured at study entry, baseline, week 12 and week 24	No
Secondary	Physical examination		performed at study entry and at last visit.	No