Lantus Versus Levemir Treat-To-Target

NCT00405418 | Completed Phase 4

• 2 other identifiers: LANTU_C_00579EUDRACT # : 2006-000324-13
• Study Type: interventional
• Target: 973
• Locations: 19 countries
• Sites: 19

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (5)

• HbA1c recorded

  At baseline, week 12 and week 24

• Self-monitored fasting BG in both treatment arms and pre-dinner BG in detemir arm

  On the 4 consecutive days before each visit

• 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

• Episodes of hypoglycemia (symptomatic, total and categorized as day-time/nocturnal, severe or asymptomatic)

  All across the study

• Self-monitored BG values whenever patient experiences symptoms possibly related to hypoglycemia.

  All across the study

Secondary Outcomes (9)

• Doses of insulin glargine or insulin detemir

  Daily

• Laboratory fasting plasma glucose

  At baseline, week 12 and week 24

• Insulinemia and fasting C-peptide level

  At baseline

• Lipid profile

  at baseline and week 24

• Patient reported outcomes (quality of life and treatment satisfaction)

  at baseline, week 4, week 12 and at the last visit

Study Arms (2)

1

EXPERIMENTAL

Insulin Glargine

Drug: Insulin glargine

2

ACTIVE COMPARATOR

Insulin Detemir

Drug: Insulin Detemir

Interventions

Insulin glargine DRUG

Subcutaneous injection, once a day in the evening

1

Insulin Detemir DRUG

Subcutaneous injection, twice a day at breakfast and before dinner

2

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• % ≤ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (20)

Sanofi-Aventis

North Ryde, Australia

Location

Sanofi-Aventis

São Paulo, Brazil

Location

Sanofi-Aventis

Laval, Canada

Location

Sanofi-Aventis

Hoersholm, Denmark

Location

Sanofi-Aventis

Helsinki, Finland

Location

Sanofi-Aventis

Berlin, Germany

Location

Sanofi-Aventis

Mumbai, India

Location

Sanofi-Aventis

Dublin, Ireland

Location

Sanofi-Aventis

Gouda, Netherlands

Location

Sanofi-Aventis

Porto Salvo, Portugal

Location

Sanofi-Aventis

Bucharest, Romania

Location

Sanofi-Aventis

Moscow, Russia

Location

Sanofi-Aventis

Belgrade, Serbia

Location

Sanofi-Aventis

Seoul, South Korea

Location

Sanofi-Aventis

Barcelona, Spain

Location

Sanofi-Aventis

Stockholm, Sweden

Location

Sanofi-Aventis

Meyrin, Switzerland

Location

Sanofi-Aventis

Taipei, Taiwan

Location

Sanofi-Aventis

Istanbul, Turkey (Türkiye)

Location

Sanofi-Aventis

Guildford, United Kingdom

Location

Related Publications (1)

• Swinnen SG, Dain MP, Aronson R, Davies M, Gerstein HC, Pfeiffer AF, Snoek FJ, Devries JH, Hoekstra JB, Holleman F. A 24-week, randomized, treat-to-target trial comparing initiation of insulin glargine once-daily with insulin detemir twice-daily in patients with type 2 diabetes inadequately controlled on oral glucose-lowering drugs. Diabetes Care. 2010 Jun;33(6):1176-8. doi: 10.2337/dc09-2294. Epub 2010 Mar 3.

  PMID: 20200301 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Insulin Detemir

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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

• Valérie Pilorget

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: November 30, 2006
• Study Start: November 1, 2006
• Primary Completion: June 1, 2008
• Last Updated: September 15, 2009

Record last verified: 2009-09

Locations

SE (1); NL (1); TW (1); TU (1); FI (1); DK (1); CH (1); RO (1); IE (1); PT (1); KR (1); RU (1); GB (1); CA (1); DE (1); BR (1); IN (1); AU (1); ES (1)