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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

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: INSULIN GLARGINE Drug: INSULIN GLULISINE Drug: PREMIXED INSULIN Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 934 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121835


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Locations
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Austria
Investigational Site Number 040-004
Sankt Stefan, Austria, A-8511
Investigational Site Number 040-002
Vienna, Austria, A-1030
Investigational Site Number 040-001
Vienna, Austria
Investigational Site Number 040-003
Vienna, Austria
Brazil
Investigational Site Number 076002
Belém, Brazil, 66073-000
Investigational Site Number 076005
Curitiba, Brazil, 80060-900
Investigational Site Number 076004
Fortaleza, Brazil, 60430-370
Investigational Site Number 076001
Porto Alegre, Brazil, 90035-001
Investigational Site Number 076003
São Paulo, Brazil, 04024-002
China
Investigational Site Number 156004
Beijing, China
Investigational Site Number 156005
Beijing, China
Investigational Site Number 156006
Beijing, China
Investigational Site Number 156011
Chongqing, China
Investigational Site Number 156009
Dalian, China
Investigational Site Number 156008
Guangzhou, China
Investigational Site Number 156012
Haikou, China
Investigational Site Number 156007
Nanjing, China
Investigational Site Number 156001
Shanghai, China
Investigational Site Number 156002
Shanghai, China
Investigational Site Number 156003
Shanghai, China
Investigational Site Number 156010
Shenyang, China
Colombia
Investigational Site Number 170001
Bogota, Colombia
Investigational Site Number 170002
Bogota, Colombia
Investigational Site Number 170003
Bucaramanga, Colombia
Investigational Site Number 170005
Manizales, Colombia, 170
Investigational Site Number 170004
Pereira, Colombia, 170
Denmark
Investigational Site Number 208-001
Hvidovre, Denmark, 2650
Investigational Site Number 208-003
København NV., Denmark, 2400
Investigational Site Number 208-002
København S., Denmark, 2300
Greece
Investigational Site Number 300006
Alexandroupolis, Greece, 68100
Investigational Site Number 300001
Athens, Greece
Investigational Site Number 300002
Athens, Greece
Investigational Site Number 300003
Athens, Greece
Investigational Site Number 300004
Athens, Greece
Investigational Site Number 300005
Iraklion, Greece, 71001
Investigational Site Number 300011
Maroussi, Athens, Greece, 15123
Investigational Site Number 300008
Thessaloniki, Greece, 546 36
Investigational Site Number 300010
Thessaloniki, Greece, 56429
Investigational Site Number 300007
Thessaloniki, Greece, 57010
India
Investigational Site Number 356008
Bangalore, India, 560043
Investigational Site Number 356003
Bangalore, India, 560052
Investigational Site Number 356007
Bangalore, India, 560092
Investigational Site Number 356006
Bhubaneshwar, India, 751019
Investigational Site Number 356001
Hyderabad, India, 500034
Investigational Site Number 356005
Hyderabad, India, 500034
Investigational Site Number 356004
Trivandrum, India
Italy
Investigational Site Number 380-010
Catania, Italy, 95122
Investigational Site Number 380-008
Catania, Italy, 95124
Investigational Site Number 380-006
Colleferro, Italy, 00034
Investigational Site Number 380-007
Foggia, Italy, 71100
Investigational Site Number 380-005
Forlì, Italy
Investigational Site Number 380-001
Genova, Italy, 16132
Investigational Site Number 380-011
Merano, Italy, 39100
Investigational Site Number 380-009
Napoli, Italy, 80131
Investigational Site Number 380-012
Napoli, Italy, 80131
Investigational Site Number 380-004
Parma, Italy, 43100
Korea, Republic of
Investigational Site Number 410004
Ansan-si, Kyouggi-do, Korea, Republic of
Investigational Site Number 410003
Koyang-si, Korea, Republic of
Investigational Site Number 410001
Seoul, Korea, Republic of
Investigational Site Number 410002
Seoul, Korea, Republic of
Kuwait
Investigational Site Number 001
Kuwait, Kuwait
Mexico
Investigational Site Number 484004
Aguascalientes, Mexico, 20020
Investigational Site Number 484001
Aguascalientes, Mexico, 20230
Investigational Site Number 484003
Guadalajara, Mexico, 44650
Investigational Site Number 484002
Guadalajara, Mexico, 44680
Investigational Site Number 484005
Puebla, Mexico, 72000
Romania
Investigational Site Number 642001
Iasi, Romania, 700111
Investigational Site Number 642002
Iasi, Romania
Investigational Site Number 642003
Oradea, Romania, 410169
Spain
Investigational Site Number 724001
Avila, Spain, 05071
Investigational Site Number 724002
Barcelona, Spain, 08022
Investigational Site Number 724008
Galdakao, Spain, 48960
Investigational Site Number 724007
Lugo, Spain, 27004
Investigational Site Number 724004
Madrid, Spain, 28805
Investigational Site Number 724009
Pamplona, Spain, 31008
Investigational Site Number 724005
Santa Coloma de Gramanet, Spain, 8923
Investigational Site Number 724003
Sevilla, Spain, 41010
Investigational Site Number 724006
Valencia, Spain, 46010
Taiwan
Investigational Site Number 158004
Changhua County, Taiwan
Investigational Site Number 158003
Hsintien, Taiwan, 23137
Investigational Site Number 158007
Kaohsiung Hsien,, Taiwan
Investigational Site Number 158006
New Taipei city, Taiwan
Investigational Site Number 158009
Taichung City, Taiwan
Investigational Site Number 158001
Taichung, Taiwan, 407
Investigational Site Number 158005
Tainan, Taiwan
Investigational Site Number 158002
Taipei, Taiwan
Turkey
Investigational Site Number 792-013
Ankara, Turkey, 06100
Investigational Site Number 792-009
Canakkale, Turkey, 17110
Investigational Site Number 792-006
Diyarbakir, Turkey, 21830
Investigational Site Number 792-004
Istanbul, Turkey, 34098
Investigational Site Number 792-001
Izmir, Turkey, 35340
Investigational Site Number 792-016
Konya, Turkey
Investigational Site Number 792-007
Sivas, Turkey, 58140
Investigational Site Number 792-005
Trabzon, Turkey
Investigational Site Number 792-002
Van, Turkey, 65080
United Arab Emirates
Investigational Site Number 784-001
Dubai, United Arab Emirates
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01121835     History of Changes
Other Study ID Numbers: LANTU_C_04589
2009-018172-33 ( EudraCT Number )
U1111-1116-9859 ( Other Identifier: UTN )
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin glulisine
Hypoglycemic Agents
Physiological Effects of Drugs