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Completed

NCT Number: NCT01121835

Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study

Primary Objective:

To demonstrate the superiority of a strategy with insulin glargine in comparison with a strategy including the premixed insulin in term of percentage of patients reaching HbA1c (glycosylated hemoglobin) below 7% at the end of treatment and who do not experience documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) below 56 mg/dL (3.1 mmol/L)) over a 24-week treatment period, in Type 2 diabetes patients failing lifestyle management and oral agents.

Secondary Objectives:

To assess the effect of insulin glargine in comparison with premixed insulin on :

* Evolution of HbA1c level during the treatment period Percentage of patients who reach the target of HbA1c < 7 % and who do not experience documented symptomatic hypoglycemia confirmed by a Plasma Glucose (PG) below 70 mg/dL (3.9 mmol/L) * Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 56 mg/dL (3.1 mmol/L) >Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 70 mg/dL (3.9 mmol/L) >Evolution of Fasting Plasma Glucose Evolution of 7-point plasma glucose profiles * Evolution of weight * Hypoglycemia occurrence * Dose of insulins * Evolution of liver function * Overall safety

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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

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigational Site Number 040-004, Sankt Stefan, Austria

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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 diagnosed for more than 1 year
  • Insulin naïve
  • Treated with lifestyle interventions and oral antidiabetic drugs, at least metformin at the maximum tolerated dose (with a minimum dose of 1g/day), for at least 3 months
  • HbA1c ≥ 7.0 % and ≤ 10.5%
  • Body mass index (BMI) ≤ 40 kg/m2
  • Ability and willingness to perform plasma glucose (PG) monitoring using the sponsor-provided glucose meter and to complete the patient diary
  • Willingness and ability to comply with the study protocol
  • Signed informed consent obtained prior any study procedure

Exclusion criteria

  • Treatment with glucagon-like peptide-1 (GLP-1) agonists in the 3 months prior to study entry
  • Previous treatment with insulin (except for treatment of gestational diabetes or brief treatment with insulin for less than 1 week)
  • Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake)
  • Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method)
  • Hospitalized patient (except for routine diabetes check-up)
  • Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by retina examination, in the 2 years prior to study entry
  • History of sensitivity to the study drugs or to drugs with a similar chemical structure
  • Impaired renal function: creatinine clearance < 60ml/min
  • Impaired liver function (ALT, AST > 3 x upper limit of normal range)
  • Severe gastro-intestinal disease
  • Treatment with corticosteroids with potential systemic action within the 3 months prior to study entry
  • Likelihood of requiring treatments during the study which are not permitted
  • Treatment with an investigational product in the 30 days prior to study entry
  • Alcohol or drug abuse within the last 5 years

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

Pharmaceutical form: solution for injection Route of administration: sub-cutaneous injection Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 ml)

insulin glulisine

Drug

Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL)

PREMIXED INSULIN

Drug

Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: - 30% soluble insulin aspart and 70 % protamine-crystallised insulin aspart in pre-filled Flexpen for all the countries except Mexico

  • 25 % insulin lispro solution and 75% insulin lispro protamine in cartridges for Humapen Luxura for Mexico only

Primary outcomes

  1. Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) ≤ 56 mg/dL [3.1 mmol/L]

    Time frame: From baseline (visit 2, week 0) to visit 14 (week 24)

Secondary outcomes

  1. 7-point plasma glucose (PG) profile recorded on 3 consecutive days

    Time frame: From baseline (visit 2, week 0) to visit 14 (week 24)

  2. Self-monitored PG (Plasma Glucose) values over 3 consecutive days

    Time frame: before visit 4 (week 2)

  3. Self-monitored PG (Plasma Glucose) values over 3 consecutive days

    Time frame: before visit 8 (week 6)

  4. Self-monitored PG (Plasma Glucose) values over 3 consecutive days

    Time frame: before visit 12 (week 16)

  5. Weight and supine blood pressure

    Time frame: From baseline (visit 2, week 0) to visit 14 (week 24)

  6. Insulin doses of the day before each visit

    Time frame: from visit 3 (week 1) to visit 14 (week 24)

  7. Biochemistry and lipid profile

    Time frame: From baseline (visit 2, week 0) to visit 14 (week 24)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A 24-week, Open, Multicenter, Comparative Study of 2 Strategies (Including Insulin Glargine Versus Premixed Insulin) for the Therapeutic Management of Patients With Type 2 Diabetes Failing Oral Agents

Acronym: GALAPAGOS

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 12, 2010
Registry last updated
Apr 4, 2013

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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