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Completed

NCT Number: NCT00949442

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

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).

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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

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigational Site Number 076-001, Fortaleza, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Insulin Glargine (HOE901) [Lantus]

Drug

100 Units/ml solution for injection in a pre-filled pen SoloStar® (3 ml)

Glimepiride

Drug

tablets of 1 and 2 mg

human insulin [NPH]

Drug

100 IU/ml suspension for injection in a prefilled pen OptiSet® (3 ml)

Primary outcomes

  1. HbA1c

    Time frame: Recorded at baseline (week 0), week 12, week 24 and week 36

Secondary outcomes

  1. Self-monitored fasting plasma glucose (FPG)

    Time frame: Before baseline (week 0), weeks 12, 24 and 36

  2. 8-points profiles

    Time frame: The week before baseline, at 12, 24 and 36 weeks

  3. Episodes of hypoglycemia

    Time frame: From the week -2 to the week 36

  4. 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

  5. Need of additional prandial insulin

    Time frame: At week 24

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: LANCELOT

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 30, 2009
Registry last updated
Aug 21, 2012

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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