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Completed

NCT Number: NCT00405418

Lantus Versus Levemir Treat-To-Target

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis, North Ryde, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glargine

Drug

Subcutaneous injection, once a day in the evening

insulin detemir

Drug

Subcutaneous injection, twice a day at breakfast and before dinner

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Acronym: L2T3

Important dates

Study start
2006
Primary completion
2008
First posted
Nov 30, 2006
Registry last updated
Sep 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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