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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01121835
First received: May 6, 2010
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: INSULIN GLARGINE
Drug: INSULIN GLULISINE
Drug: PREMIXED INSULIN
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 7-point plasma glucose (PG) profile recorded on 3 consecutive days [ Time Frame: From baseline (visit 2, week 0) to visit 14 (week 24) ] [ Designated as safety issue: No ]
  • Self-monitored PG (Plasma Glucose) values over 3 consecutive days [ Time Frame: before visit 4 (week 2) ] [ Designated as safety issue: No ]
  • Self-monitored PG (Plasma Glucose) values over 3 consecutive days [ Time Frame: before visit 8 (week 6) ] [ Designated as safety issue: No ]
  • Self-monitored PG (Plasma Glucose) values over 3 consecutive days [ Time Frame: before visit 12 (week 16) ] [ Designated as safety issue: No ]
  • Weight and supine blood pressure [ Time Frame: From baseline (visit 2, week 0) to visit 14 (week 24) ] [ Designated as safety issue: No ]
  • Insulin doses of the day before each visit [ Time Frame: from visit 3 (week 1) to visit 14 (week 24) ] [ Designated as safety issue: No ]
  • Biochemistry and lipid profile [ Time Frame: From baseline (visit 2, week 0) to visit 14 (week 24) ] [ Designated as safety issue: No ]

Enrollment: 934
Study Start Date: February 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin glargine

Administered once a day in the evening, at the same time every day. The starting daily dose is 0.2 U/Kg of body weight or 12 U, at the investigator's decision.

Insulin glulisine is administered for patients of the insulin glargine group requiring insulin glulisine at week 12 (visit 11).

Insulin glulisine is administered prior (10-15 min) to the main meal of the day, which is the meal with highest Post-Prandial Plasma Glucose (PPPG) on the 3 profiles performed before week 12.

Starting dose is of 4 units per day.

Drug: INSULIN GLARGINE
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)
Drug: INSULIN GLULISINE
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)
Experimental: Premixed insulin
administered once a day (in the evening at dinner) or twice a day (in the morning before breakfast and in the evening at dinner). Starting daily dose will be 6 U at breakfast and 6 U at dinner, if administered twice a day or 12 U at dinner if administered once a day
Drug: PREMIXED INSULIN

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

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121835

  Show 96 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01121835     History of Changes
Other Study ID Numbers: LANTU_C_04589, 2009-018172-33, U1111-1116-9859
Study First Received: May 6, 2010
Last Updated: April 2, 2013
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin glulisine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014