Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients | RxWiki

Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients

Overview[ - collapse ][ - ]

Purpose	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
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Insulin Glargine Drug: Sitagliptin Drug: Metformin
Phase	Phase 4
Sponsor	Sanofi
Responsible Party	Sanofi
ClinicalTrials.gov Identifier	NCT00751114
First Received	September 10, 2008
Last Updated	September 3, 2012
Last verified	September 2012

Tracking Information[ + expand ][ + ]

First Received Date	September 10, 2008
Last Updated Date	September 3, 2012
Start Date	November 2008
Estimated Primary Completion Date	July 2011
Current Primary Outcome Measures	HbA1c: Change From Baseline to Study Endpoint [Time Frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14] [Designated as safety issue: No]Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period.
Current Secondary Outcome Measures	HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint [Time Frame: study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14] [Designated as safety issue: No] HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint [Time Frame: study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14] [Designated as safety issue: No] Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint [Time Frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value] [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). Study endpoint was defined as the last available SMFPG mean value collected on-treatment. Change= study endpoint - baseline 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint [Time Frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14] [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 in the Insulin Glargine Group [Time Frame: visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16), visit 14 (week 24), first dose received defined as first available value, study endpoint defined as last available value] [Designated as safety issue: No]Daily dose at the face-to-face visits. Lipid Profile: Change From Baseline to Study Endpoint [Time Frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14] [Designated as safety issue: No] Change in Body Weight From Baseline to Study Endpoint [Time Frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value] [Designated as safety issue: Yes] Number of Patients With at Least One Episode of Symptomatic Hypoglycemia [Time Frame: During the treatment phase (24 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] Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia [Time Frame: During the treatment phase (24 weeks) plus 7 days after last dose] [Designated as safety issue: Yes]Severe symptomatic hypoglycemia was defined as an event with clinical symptoms which required assistance of another person and with either a Plasma Glucose level < 36 mg/dL (2 mmol/L) or with a prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration

Descriptive Information[ + expand ][ + ]

Brief Title	Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients
Official Title	Superiority Study of Insulin Glargine Over Sitagliptin in Insulin-naïve Patients With Type 2 Diabetes Treated With Metformin and Not Adequately Controlled
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
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel 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 pre-filled SoloStar® pen (3 mL). Other Names: Lantus®Drug: Sitagliptin Oral administration. 100 mg film-coated tablets. Other Names: Januvia®Drug: Metformin Patients continued with metformin as usual oral anti-diabetic treatment.
Study Arm (s)	Experimental: 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 Active Comparator: Sitagliptin Dose of 100 mg once a day administered with or without food.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	515
Estimated Completion Date	July 2011
Estimated Primary Completion Date	July 2011
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.
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, Turkey, United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number	NCT00751114
Other Study ID Numbers	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	Istanbul, Turkey
Sanofi-Aventis Administrative Office	Guildford Surrey, United Kingdom