Clinical trial NCT00851903: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-02-26
Enrollment: 112
Sex: ALL
Minimum age (years): 35
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period)
timeFrame: study endpoint: week 12 or earlier in case of premature discontinuation
Secondary outcomes:
measure: HbA1c: Change From Baseline to Study Endpoint
timeFrame: baseline, study endpoint: week 12 or earlier in case of premature discontinuation
measure: Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint
timeFrame: baseline, study endpoint: week 12 or week 8 if value not available at week 12
measure: 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint
timeFrame: baseline, study endpoint: week 12 or week 8 if value not available at week 12
measure: Insulin Dose
timeFrame: baseline, week 4, week 8, week 12
measure: Number of Patients With at Least One Episode of Symptomatic Hypoglycemia
timeFrame: During the treatment period (12 weeks) plus 7 days after last dose
measure: Change in Body Weight From Baseline to Study Endpoint
timeFrame: baseline, study endpoint: week 12 or week 8 or week 4 depending on last available value
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Vienna
country: Austria
facility: Sanofi-Aventis Administrative Office
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
city: Bogota
country: Colombia
facility: Sanofi-Aventis Administrative Office
city: Cairo
country: Egypt
facility: Sanofi-Aventis Administrative Office
city: Kallithea
country: Greece
facility: Sanofi-Aventis Administrative Office
city: Hong Kong
country: Hong Kong
facility: Sanofi-Aventis Administrative Office
city: Mumbai
country: India
facility: Sanofi-Aventis Administrative Office
city: Natanya
country: Israel
facility: Sanofi-Aventis Administrative Office
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Administrative Office
city: Beirut
country: Lebanon
facility: Sanofi-Aventis Administrative Office
city: Col. Coyoacan
country: Mexico
facility: Sanofi-Aventis Administrative Office
city: Gouda
country: Netherlands
facility: Sanofi-Aventis Administrative Office
city: Porto Salvo
country: Portugal
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Guildford Surrey
country: United Kingdom
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: