Superiority study of insulin glargine over sitagliptin in insulin-naïve patients with type 2 diabetes treated with metformin and not adequately controlled - EASIE

• Register: EUCTR
• Last refreshed on: 3 September 2012
• Main ID: EUCTR2008-000516-32-NL
• Date of registration: 06/06/2008
• Prospective Registration: Yes
• Primary sponsor: sanofi aventis Groupe
• Public title: Superiority study of insulin glargine over sitagliptin in insulin-naïve patients with type 2 diabetes treated with metformin and not adequately controlled - EASIE
• Scientific title: Superiority study of insulin glargine over sitagliptin in insulin-naïve patients with type 2 diabetes treated with metformin and not adequately controlled - EASIE
• Date of first enrolment: 04/08/2008
• Target sample size: 530
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000516-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Austria, Greece, Netherlands, Portugal, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients aged from 35 to 70 years, inclusively,
2. With type 2 Diabetes diagnosed for at least 6 months,
3. Not previously treated with insulin,
4. On metformin for at least 3 months and:
- With a stable minimal dose of 1.7 g/day for at least 2 months,
- Or if metformin is poorly tolerated, with a stable minimal dose of 1 g/day for at least 2 months,
5. HbA1c = 7 and < 11 %,
6. BMI between 25 and 45 kg/m2, inclusively,
7. Ability and willingness to perform plasma glucose (PG) monitoring using the Sponsor-provided PG meter and to complete the patient diary,
8. Signed informed consent obtained prior any study procedure,
9. Willingness and ability to comply with the study protocol.



Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Treatment with oral antidiabetic drugs other than metformin within the last 3 months,
2. Treatment with the combination of metformin + sulfonylurea for more than 1 year,
3. Previous treatment with GLP-1 agonists or DPP IV inhibitors,
4. FPG (assessed by central laboratory measurement) = 280 mg/dL (15.4 mmol/L),
5. Diabetes other than type 2 diabetes,
6. Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method),
7. In-patient care,
8. 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,
9. Impaired renal function: serum creatinine = 1.5 mg/dL (= 133 µmol/L) or = 1.4 mg/dL (= 124 µmol/L) in men and women, respectively,
10. History of sensitivity to the study drugs or to drugs with a similar chemical structure,
11. Impaired hepatic function (ALAT, ASAT > 3 x upper limit of normal range),
12. Treatment with systemic corticosteroids within the 3 months prior to study entry or likehood of requiring treatment during the study that are not permitted during the study,
13. Alcohol or drug abuse in the last year,
14. Night shift worker
15. 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.




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 diabetes treated with metformin and not adequately controlled
MedDRA version: 9.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control

Intervention(s)

Trade Name: Lantus
Pharmaceutical Form: Solution for injection
INN or Proposed INN: insulin glargine
CAS Number: 160337-95-1
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Januvia
Pharmaceutical Form: Tablet
INN or Proposed INN: sitagliptin
CAS Number: 790712-60-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Main Objective: The primary objective of this study is to demonstrate the superiority of insulin glargine over sitagliptin in reducing HbA1c from baseline to the end of the treatment period.

Secondary Objective: The secondary objectives of this study are to assess the effect of insulin glargine in comparison with sitagliptin on:
Efficacy parameters:
• HbA1c levels
• Fasting Plasma Glucose
• 7-point plasma glucose profiles
• Percentage of patients with HbA1c <7% and <6.5%

Safety parameters:
• Hypoglycemia occurrence
• Body weight
• Overall safety

Primary end point(s): The primary efficacy variable will be the change in HbA1c from baseline to study endpoint.
The study endpoint is defined as the last available HbA1c value measured during the study treatment phase plus 14 days after last dose.

Secondary ID(s)

LANTU_C_02761