Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial

NCT ID: NCT00851903

Last Updated: 2012-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-09-30

Brief Summary

This study was the extension of the LANTU_C_02761 study named EASIE and identified as NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve patients treated with metformin and not adequately controlled).

All patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the core study had the possibility to enter this extension study if they met the other inclusion criteria and did not present with any exclusion criteria.

The visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension study which consisted of a 12-week treatment period.

The objectives of this extension study were:

• To assess the glycemic control (HbA1c <7%) of a 3-month combination therapy with metformin, insulin glargine and sitagliptin in patients not adequately controlled by a previous treatment with metformin plus either insulin glargine or sitagliptin.
• To assess the effect of insulin glargine in combination with sitagliptin on HbA1c level, fasting plasma glucose, 7-point glucose profile, hypoglycemia occurrence, body weight and overall safety.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination insulin glargine and sitagliptin

Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 < Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).

Sitagliptin: stable dose of 100 mg once a day administered with or without food.

Group Type: EXPERIMENTAL

Insulin Glargine

Intervention Type: DRUG

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

Sitagliptin

Intervention Type: DRUG

Oral administration. 100mg 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 prefilled SoloStar® pen (3 mL).

Intervention Type: DRUG

Sitagliptin

Oral administration. 100mg 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

• Patients who completed the core study LANTU_C_02761 (NCT00751114) i.e. went through the visit 14 investigation,
• HbA1c >= 7 %,
• Ability and willingness to perform plasma blood glucose monitoring using the sponsor-provided plasma glucose meter and to complete the patient dairy,
• Signed informed consent obtained prior any study procedure,
• Willingness and ability to comply with the study protocol.

Exclusion Criteria

• Treatment with oral antidiabetic drugs other than metformin and sitagliptin in the core study,
• Treatment with insulin other than Insulin Glargine in the core study (except in case of an emergency, for a period of time less than 7 days),
• Treatment with a non-permitted drug during the core study,
• Pregnant or lactating women,
• 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 in the core study),
• 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,
• 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),
• History of pancreatitis.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 71 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

Guildford Surrey, , United Kingdom

Countries

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

Other Identifiers

2008-000521-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EXT_LANTU_C_02761

Identifier Type: -

Identifier Source: org_study_id