Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients

NCT ID: NCT00751114

Last Updated: 2012-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 515 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-07-31

Brief Summary

The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period.

Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on:

• HbA1c level
• Fasting Plasma Glucose (FPG)
• 7-point plasma glucose (PG) profiles
• Percentage of patients with HbA1c <7% and <6.5%

Safety objectives consisted of:

• Hypoglycemia occurrence
• Body weight
• Overall safety

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin Glargine

Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L).

Group Type: EXPERIMENTAL

Insulin Glargine

Intervention Type: DRUG

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

Metformin

Intervention Type: DRUG

Patients continued with metformin as usual oral anti-diabetic treatment.

Sitagliptin

Dose of 100 mg once a day administered with or without food.

Group Type: ACTIVE_COMPARATOR

Sitagliptin

Intervention Type: DRUG

Oral administration. 100 mg film-coated tablets.

Metformin

Intervention Type: DRUG

Patients continued with metformin as usual oral anti-diabetic treatment.

Interventions

Insulin Glargine

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

Intervention Type: DRUG

Sitagliptin

Oral administration. 100 mg film-coated tablets.

Intervention Type: DRUG

Metformin

Patients continued with metformin as usual oral anti-diabetic treatment.

Intervention Type: DRUG

Other Intervention Names

Lantus®; Januvia®

Eligibility Criteria

Inclusion Criteria

• With type 2 diabetes diagnosed for at least 6 months,
• Not previously treated with insulin,
• On metformin for at least 3 months and a stable minimal dose of 1 g/day for at least 2 months
• HbA1c ≥ 7 and < 11 %,
• Body Mass Index (BMI) between 25 and 45 kg/m² inclusively,
• Ability and willingness to perform plasma glucose (PG) monitoring using the Sponsor-provided PG meter and to complete the patient diary,
• Signed informed consent obtained prior any study procedures,
• Willingness and ability to comply with the study protocol.

Exclusion Criteria

• Treatment with oral antidiabetic drugs other than metformin within the last 3 months,
• Previous treatment with the combination of metformin + sulfonylurea for more than 1 year,
• Previous treatment with Glucagon Like Peptide-1 (GLP-1) agonists or DiPeptidyl Peptidase (DPP) IV inhibitors,
• FPG (assessed by central laboratory measurement) ≥ 280 mg/dL (15.4 mmol/L),
• Diabetes other than type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agents intake...),
• Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method),
• In-patient care,
• 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 ≥ 1.5 mg/dL (≥ 133µmol/L) or ≥ 1.4 mg/dL (≥ 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: alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 3 x upper limit of normal range,
• Treatment with systemic corticosteroids within the 3 months prior to study entry or likelihood of requiring treatment during the study that are not permitted during the study (exception: in case of chronic adrenal insufficiency, systemic glucosteroids are accepted only if the disease is stable and the treatment dose stable for at least 3 months before study entry),
• Alcohol or drug abuse within the last year,
• Night shift worker,
• 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,
• Treatment with weight loss medications (e.g. sibutramine, orlistat, rimonabant) within the last 3 months,
• Participation in another clinical trial within the month prior to visit 1,
• History of pancreatitis.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Vienna, , Austria

Sanofi-Aventis Administrative Office

São Paulo, , Brazil

Sanofi-Aventis Administrative Office

Bogotá, , Colombia

Sanofi-Aventis Administrative Office

Cairo, , Egypt

Sanofi-Aventis Administrative Office

Kallithea, , Greece

Sanofi-Aventis Administrative Office

Hong Kong, , Hong Kong

Sanofi-Aventis Administrative Office

Mumbai, , India

Sanofi-Aventis Administrative Office

Netanya, , Israel

Sanofi-Aventis Administrative Office

Beirut, , Lebanon

Sanofi-Aventis Administrative Office

Col. Coyoacan, , Mexico

Sanofi-Aventis Administrative Office

Gouda, , Netherlands

Sanofi-Aventis Administrative Office

Porto Salvo, , Portugal

Sanofi-Aventis Administrative Office

Seoul, , South Korea

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Sanofi-Aventis Administrative Office

Istanbul, , Turkey (Türkiye)

Sanofi-Aventis Administrative Office

Guildford Surrey, , United Kingdom

Countries

Romania; United States; Austria; Brazil; Colombia; Egypt; Greece; Hong Kong; India; Israel; Lebanon; Mexico; Netherlands; Portugal; South Korea; Spain; Turkey (Türkiye); United Kingdom

References

Aschner P, Chan J, Owens DR, Picard S, Wang E, Dain MP, Pilorget V, Echtay A, Fonseca V; EASIE investigators. Insulin glargine versus sitagliptin in insulin-naive patients with type 2 diabetes mellitus uncontrolled on metformin (EASIE): a multicentre, randomised open-label trial. Lancet. 2012 Jun 16;379(9833):2262-9. doi: 10.1016/S0140-6736(12)60439-5. Epub 2012 Jun 9.

Reference Type: RESULT

PMID: 22683131 (View on PubMed)

Chan JC, Aschner P, Owens DR, Picard S, Vincent M, Dain MP, Pilorget V, Loizeau V, Echtay A, Fonseca V. Triple combination of insulin glargine, sitagliptin and metformin in type 2 diabetes: the EASIE post-hoc analysis and extension trial. J Diabetes Complications. 2015 Jan-Feb;29(1):134-41. doi: 10.1016/j.jdiacomp.2014.08.007. Epub 2014 Aug 27.

Reference Type: DERIVED

PMID: 25283485 (View on PubMed)

Other Identifiers

2008-000516-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LANTU_C_02761

Identifier Type: -

Identifier Source: org_study_id