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Lantus Versus Levemir Treat-To-Target (L2T3)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Insulin glargine
Insulin Detemir
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Insulin Glargine

Insulin Detemir

Outcomes

Primary Outcome Measures

HbA1c recorded
Self-monitored fasting BG in both treatment arms and pre-dinner BG in detemir arm
Self-monitored BG values from 8-point 24-hour profile recorded on 2 consecutive days
Episodes of hypoglycemia (symptomatic, total and categorized as day-time/nocturnal, severe or asymptomatic)
Self-monitored BG values whenever patient experiences symptoms possibly related to hypoglycemia.

Secondary Outcome Measures

Doses of insulin glargine or insulin detemir
Laboratory fasting plasma glucose
Insulinemia and fasting C-peptide level
Lipid profile
Patient reported outcomes (quality of life and treatment satisfaction)
Safety data: occurrence of adverse events and weight
Waist and hip circumferences
Systolic and diastolic blood pressure
Physical examination

Full Information

First Posted
November 29, 2006
Last Updated
September 14, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00405418
Brief Title
Lantus Versus Levemir Treat-To-Target
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
973 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Insulin Glargine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Insulin Detemir
Intervention Type
Drug
Intervention Name(s)
Insulin glargine
Intervention Description
Subcutaneous injection, once a day in the evening
Intervention Type
Drug
Intervention Name(s)
Insulin Detemir
Intervention Description
Subcutaneous injection, twice a day at breakfast and before dinner
Primary Outcome Measure Information:
Title
HbA1c recorded
Time Frame
At baseline, week 12 and week 24
Title
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
Title
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
Title
Episodes of hypoglycemia (symptomatic, total and categorized as day-time/nocturnal, severe or asymptomatic)
Time Frame
All across the study
Title
Self-monitored BG values whenever patient experiences symptoms possibly related to hypoglycemia.
Time Frame
All across the study
Secondary Outcome Measure Information:
Title
Doses of insulin glargine or insulin detemir
Time Frame
Daily
Title
Laboratory fasting plasma glucose
Time Frame
At baseline, week 12 and week 24
Title
Insulinemia and fasting C-peptide level
Time Frame
At baseline
Title
Lipid profile
Time Frame
at baseline and week 24
Title
Patient reported outcomes (quality of life and treatment satisfaction)
Time Frame
at baseline, week 4, week 12 and at the last visit
Title
Safety data: occurrence of adverse events and weight
Time Frame
assessed at each visit
Title
Waist and hip circumferences
Time Frame
measured at baseline, week 12 and week 24
Title
Systolic and diastolic blood pressure
Time Frame
measured at study entry, baseline, week 12 and week 24
Title
Physical examination
Time Frame
performed at study entry and at last visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie Pilorget
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
North Ryde
Country
Australia
Facility Name
Sanofi-Aventis
City
Sao Paolo
Country
Brazil
Facility Name
Sanofi-Aventis
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis
City
Hoersholm
Country
Denmark
Facility Name
Sanofi-Aventis
City
Helsinki
Country
Finland
Facility Name
Sanofi-Aventis
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis
City
Mumbai
Country
India
Facility Name
Sanofi-Aventis
City
Dublin
Country
Ireland
Facility Name
Sanofi-Aventis
City
Seoul
Country
Korea, Republic of
Facility Name
Sanofi-Aventis
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis
City
Porto Salvo
Country
Portugal
Facility Name
Sanofi-Aventis
City
Bucharest
Country
Romania
Facility Name
Sanofi-Aventis
City
Moscow
Country
Russian Federation
Facility Name
Sanofi-Aventis
City
Belgrade
Country
Serbia
Facility Name
Sanofi-Aventis
City
Barcelona
Country
Spain
Facility Name
Sanofi-Aventis
City
Stockholm
Country
Sweden
Facility Name
Sanofi-Aventis
City
Meyrin
Country
Switzerland
Facility Name
Sanofi-Aventis
City
Taipe
Country
Taiwan
Facility Name
Sanofi-Aventis
City
Istanbul
Country
Turkey
Facility Name
Sanofi-Aventis
City
Guildford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20200301
Citation
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.
Results Reference
derived

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Lantus Versus Levemir Treat-To-Target

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