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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Insulin Glargine Drug: Sitagliptin Drug: Metformin
Phase	Phase 3
Sponsor	Sanofi
Responsible Party	Sanofi
ClinicalTrials.gov Identifier	NCT00851903
First Received	February 25, 2009
Last Updated	September 3, 2012
Last verified	September 2012

Tracking Information[ + expand ][ + ]

First Received Date	February 25, 2009
Last Updated Date	September 3, 2012
Start Date	June 2009
Estimated Primary Completion Date	September 2011
Current Primary Outcome Measures	HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period) [Time Frame: study endpoint: week 12 or earlier in case of premature discontinuation] [Designated as safety issue: No]
Current Secondary Outcome Measures	HbA1c: Change From Baseline to Study Endpoint [Time Frame: baseline, study endpoint: week 12 or earlier in case of premature discontinuation] [Designated as safety issue: No]Change = study endpoint - baseline Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint [Time Frame: baseline, study endpoint: week 12 or week 8 if value not available at week 12] [Designated as safety issue: No]SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed). Change = study endpoint - baseline. 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint [Time Frame: baseline, study endpoint: week 12 or week 8 if value not available at week 12] [Designated as safety issue: No]7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime. Change = study endpoint - baseline. Insulin Dose [Time Frame: baseline, week 4, week 8, week 12] [Designated as safety issue: No]Daily dose at the face-to-face visits Number of Patients With at Least One Episode of Symptomatic Hypoglycemia [Time Frame: During the treatment period (12 weeks) plus 7 days after last dose] [Designated as safety issue: Yes]Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement <= 70mg/dL [3.9 mmol/L] Change in Body Weight From Baseline to Study Endpoint [Time Frame: baseline, study endpoint: week 12 or week 8 or week 4 depending on last available value] [Designated as safety issue: Yes]Change = study endpoint - baseline

Descriptive Information[ + expand ][ + ]

Brief Title	Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial
Official Title	Combination Therapy of Insulin Glargine and Sitagliptin in Patients With Type 2 Diabetes Not Adequately Controlled by a Previous Treatment With Metformin and Either Insulin Glargine or Sitagliptin
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Insulin Glargine Subcutaneous injection. 100 Units/mL solution for injection in a prefilled SoloStar® pen (3 mL). Other Names: Lantus®Drug: Sitagliptin Oral administration. 100mg film-coated tablets. Other Names: Januvia®Drug: Metformin Patients continued with metformin as usual oral anti-diabetic treatment.
Study Arm (s)	Experimental: 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 Sitagliptin: stable dose of 100 mg once a day administered with or without food.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	112
Estimated Completion Date	September 2011
Estimated Primary Completion Date	September 2011
Eligibility Criteria	Inclusion criteria: - Patients who completed the core study LANTU_C_02761 (NCT00751114) i.e. went through the visit 14 investigation, - HbA1c >= 7 %, - Dose of metformin compliant with the inclusion criteria of the core study (i.e. at least 1 g/day), and maintained stable for the duration of the core study - 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.
Gender	Both
Ages	35 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States, Austria, Brazil, Colombia, Egypt, Greece, Hong Kong, India, Israel, Korea, Republic of, Lebanon, Mexico, Netherlands, Portugal, Spain, United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number	NCT00851903
Other Study ID Numbers	EXT_LANTU_C_02761
Has Data Monitoring Committee	Not Provided
Information Provided By	Sanofi
Study Sponsor	Sanofi
Collaborators	Not Provided
Investigators	Study Director: Clinical Sciences & Operations Sanofi
Verification Date	September 2012

Locations[ + expand ][ + ]

Sanofi-Aventis Administrative Office	Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office	Vienna, Austria
Sanofi-Aventis Administrative Office	Sao Paulo, Brazil
Sanofi-Aventis Administrative Office	Bogota, 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	Natanya, Israel
Sanofi-Aventis Administrative Office	Seoul, Korea, Republic of
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	Barcelona, Spain
Sanofi-Aventis Administrative Office	Guildford Surrey, United Kingdom