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Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment (LANCELOT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00949442
First received: July 27, 2009
Last updated: August 20, 2012
Last verified: August 2012
History of Changes
  Purpose

Primary Objective:

To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period.

Secondary Objective:

To compare between treatment groups:

  • Plasma glucose (fasting, nocturnal) over time,
  • Changes from baseline in HbA1c over time,
  • Percentage of patients who reach the target of HbA1c <7 and <6.5,
  • Use of prandial insulin as rescue medication at month 6,
  • Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe),
  • Daily dose of insulin,
  • Change in body weight from baseline,
  • Evolution of 8-point plasma-glucose (PG) profiles,
  • Overall safety,
  • Patient reported outcomes (treatment satisfaction).

Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Insulin Glargine (HOE901) [Lantus]
Drug: Glimepiride
Drug: human insulin [NPH]
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Superiority of Insulin Glargine Lantus vs. NPH: Treat to Normoglycemia Concept.Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-nave People With Type 2 Diabetes Mellitus Treated With at Least One OAD and Not Adequately Controlled

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • HbA1c [ Time Frame: Recorded at baseline (week 0), week 12, week 24 and week 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-monitored fasting plasma glucose (FPG) [ Time Frame: Before baseline (week 0), weeks 12, 24 and 36 ] [ Designated as safety issue: No ]
  • 8-points profiles [ Time Frame: The week before baseline, at 12, 24 and 36 weeks ] [ Designated as safety issue: No ]
  • Episodes of hypoglycemia [ Time Frame: From the week -2 to the week 36 ] [ Designated as safety issue: No ]
  • Daily doses of insulin [ Time Frame: At week 1, week 2, week 3, week 4, week 6, week 8, week 10, week 12, week 14, week 16, week 20, week 24, week 28, week 32, week 36 ] [ Designated as safety issue: No ]
  • Need of additional prandial insulin [ Time Frame: At week 24 ] [ Designated as safety issue: No ]

Enrollment: 708
Study Start Date: July 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

Before randomization (common with arm 2):

2 weeks of Screening phase: Oral Anti Diabetics (OAD) 2 weeks of Run-In phase: switch of OAD (Sulfonylurea (except Glimepiride), glinides or alpha-glucosidase inhibitor) to Glimepiride

After randomization:

36 weeks of study treatment phase: Insulin Glargine + OAD(s) at stable dose

 Drug: Insulin Glargine (HOE901) [Lantus]
100 Units/ml solution for injection in a pre-filled pen SoloStar® (3 ml)
Drug: Glimepiride
tablets of 1 and 2 mg
Active Comparator: 2

Before randomization (common with arm 1):

2 weeks of Screening phase: Oral Anti Diabetics (OAD) 2 weeks of Run-In phase: switch of OAD (Sulfonylurea (except Glimepiride), glinides or alpha-glucosidase inhibitor) to Glimepiride

After randomization:

36 weeks of study treatment phase: NPH + OAD(s) at stable dose

 Drug: Glimepiride
tablets of 1 and 2 mg
Drug: human insulin [NPH]
100 IU/ml suspension for injection in a prefilled pen OptiSet® (3 ml)

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Insulin-naïve type 2 diabetes mellitus
  • Type 2 diabetes mellitus diagnosed for at least 1 year
  • Treated with at least one OAD (Metformin [daily dose of at least 1000mg], Sulfonylurea, glinides or alpha-glucosidase inhibitor) at stable dose for at least 3 months.
  • HbA1c > or = 7.0% and < or = 10.5%
  • BMI < 40 kg/m²
  • Ability and willingness to perform plasma glucose monitoring using the sponsor-provided glucose meter and patient diary at home
  • Informed consent obtained in writing at enrolment into the study
  • Willingness and ability to comply with the study protocol

Exclusion criteria:

  • Treatment with GLP-1 agonists or with DPP-IV inhibitors in the 3 months prior to study entry
  • Treatment with TZD as monotherapy
  • Diabetes mellitus other than Type 2 (e.g. secondary to pancreatic disorders, drugs or chemical agents intake...)
  • Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry)
  • Impaired renal function: serum creatinine > or =1.5 mg/dL (> or = 133µmol/L) or > or = 1.4 mg/dL (> or = 124 µmol/L) in men and women, respectively
  • History of sensitivity to the study drugs or to drugs with a similar chemical structure
  • Impaired hepatic function (ALT and/or AST > 3 x upper limit of normal range)
  • Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method),
  • Treatment with systemic corticosteroids within the 3 months prior to study entry or likelihood of requiring treatments during the study which are not permitted.
  • Treatment with an investigational product in the 30 days prior to visit 1
  • Alcohol or drug abuse in the last year
  • Presence of any condition (medical, psychological, social or geographical), current or anticipated that the Investigator feels would compromise the patient's safety or limit the patient successful participation in the study (including night shift worker)

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: NCT00949442

  Show 87 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Valerie Pilorget, MD Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00949442     History of Changes
Other Study ID Numbers: LANTU_C_02762, EUDRACT #: 2007-006640-22
Study First Received: July 27, 2009
Last Updated: August 20, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Glargine
Insulin
Hypoglycemic Agents
 Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013