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

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ClinicalTrials.gov Identifier: NCT01121835
Recruitment Status : Completed
First Posted : May 12, 2010
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE May 6, 2010
First Posted Date  ICMJE May 12, 2010
Last Update Posted Date April 4, 2013
Study Start Date  ICMJE February 2010
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2010)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01121835 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2010)
  • 7-point plasma glucose (PG) profile recorded on 3 consecutive days [ Time Frame: From baseline (visit 2, week 0) to visit 14 (week 24) ]
  • Self-monitored PG (Plasma Glucose) values over 3 consecutive days [ Time Frame: before visit 4 (week 2) ]
  • Self-monitored PG (Plasma Glucose) values over 3 consecutive days [ Time Frame: before visit 8 (week 6) ]
  • Self-monitored PG (Plasma Glucose) values over 3 consecutive days [ Time Frame: before visit 12 (week 16) ]
  • Weight and supine blood pressure [ Time Frame: From baseline (visit 2, week 0) to visit 14 (week 24) ]
  • Insulin doses of the day before each visit [ Time Frame: from visit 3 (week 1) to visit 14 (week 24) ]
  • Biochemistry and lipid profile [ Time Frame: From baseline (visit 2, week 0) to visit 14 (week 24) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study
Official Title  ICMJE 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
Brief Summary

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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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)
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: INSULIN GLARGINE
    • Drug: INSULIN GLULISINE
  • 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
    Intervention: Drug: PREMIXED INSULIN
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2012)
934
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2010)
870
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Brazil,   China,   Colombia,   Denmark,   Greece,   India,   Italy,   Korea, Republic of,   Kuwait,   Mexico,   Romania,   Spain,   Taiwan,   Turkey,   United Arab Emirates
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01121835
Other Study ID Numbers  ICMJE LANTU_C_04589
2009-018172-33 ( EudraCT Number )
U1111-1116-9859 ( Other Identifier: UTN )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP