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

Diabetes Mellitus, Type 2 Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851903
• Other study ID #: EXT_LANTU_C_02761
• Secondary ID: 2008-000521-19
• Status: Completed
• Phase: Phase 3
• First received: February 25, 2009
• Last updated: September 3, 2012
• Start date: June 2009
• Est. completion date: September 2011

Study information

• Verified date: September 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 71 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin Glargine
Subcutaneous injection. 100 Units/mL solution for injection in a prefilled SoloStar® pen (3 mL).
• Sitagliptin
Oral administration. 100mg film-coated tablets.
• Metformin
Patients continued with metformin as usual oral anti-diabetic treatment.

Locations

Country	Name	City	State
Austria	Sanofi-Aventis Administrative Office	Vienna
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo
Colombia	Sanofi-Aventis Administrative Office	Bogota
Egypt	Sanofi-Aventis Administrative Office	Cairo
Greece	Sanofi-Aventis Administrative Office	Kallithea
Hong Kong	Sanofi-Aventis Administrative Office	Hong Kong
India	Sanofi-Aventis Administrative Office	Mumbai
Israel	Sanofi-Aventis Administrative Office	Natanya
Korea, Republic of	Sanofi-Aventis Administrative Office	Seoul
Lebanon	Sanofi-Aventis Administrative Office	Beirut
Mexico	Sanofi-Aventis Administrative Office	Col. Coyoacan
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Portugal	Sanofi-Aventis Administrative Office	Porto Salvo
Spain	Sanofi-Aventis Administrative Office	Barcelona
United Kingdom	Sanofi-Aventis Administrative Office	Guildford Surrey
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Austria,  Brazil,  Colombia,  Egypt,  Greece,  Hong Kong,  India,  Israel,  Korea, Republic of,  Lebanon,  Mexico,  Netherlands,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period)		study endpoint: week 12 or earlier in case of premature discontinuation	No
Secondary	HbA1c: Change From Baseline to Study Endpoint	Change = study endpoint - baseline	baseline, study endpoint: week 12 or earlier in case of premature discontinuation	No
Secondary	Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint	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.	baseline, study endpoint: week 12 or week 8 if value not available at week 12	No
Secondary	7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint	7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime.; Change = study endpoint - baseline.	baseline, study endpoint: week 12 or week 8 if value not available at week 12	No
Secondary	Insulin Dose	Daily dose at the face-to-face visits	baseline, week 4, week 8, week 12	No
Secondary	Number of Patients With at Least One Episode of Symptomatic Hypoglycemia	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]	During the treatment period (12 weeks) plus 7 days after last dose	Yes
Secondary	Change in Body Weight From Baseline to Study Endpoint	Change = study endpoint - baseline	baseline, study endpoint: week 12 or week 8 or week 4 depending on last available value	Yes