Efficacy of BI 10773 versus placebo and sitagliptin over 24 weeks in patients with type 2 diabetes

• Register: EUCTR
• Last refreshed on: 4 January 2022
• Main ID: EUCTR2009-016243-20-BE
• Date of registration: 07/07/2010
• Prospective Registration: Yes
• Primary sponsor: SCS Boehringer Ingelheim Comm.V
• Public title: Efficacy of BI 10773 versus placebo and sitagliptin over 24 weeks in patients with type 2 diabetes
• Scientific title: A phase III randomised, double-blind, placebo-controlled parallel group efficacy and safety study of BI 10773 and sitagliptin administered orally over 24 weeks, in drug naïve patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet and exercise.
• Date of first enrolment: 26/10/2010
• Target sample size: 1680
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016243-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: open-label arm; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: yes; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Ireland

Contacts

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

Key inclusion & exclusion criteria

Inclusion criteria:
1. Diagnosis of type 2 diabetes mellitus prior to informed consent
2. Male and female patients on diet and exercise regimen who are drug-naïve, defined as absence of any oral or injectable anti-diabetes therapy for 12 weeks prior to randomisation or start of active open-label treatment (25 mg BI 10773)
3. HbA1c
- = 7.0% and <= 10.0% at Visit 1 (screening) in order to be eligible for randomised treatment
- > 10.0% at visit 1 (screening) in order to be eligible for the open-label BI 10773 arm
4. Age >= 20 (Japan)
Age >= 18 (countries other than Japan)
5. BMI <= 45 kg/m2 (Body Mass Index) at Visit 1 (screening)
6. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation

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. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
2. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
3. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) during screening and/or run-in phase
4. Impaired renal function, defined as eGFR<50 ml/min (moderate to severe renal impairment; MDRD formula)
5. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
6. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
7. Contraindications to sitagliptin according to the local label
8. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia)
9. Treatment with any anti-diabetes drug within 12 weeks prior to randomisation or start of active open-label treatment (25 mg BI 10773)
10. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
11. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM.
12. Pre-menopausal women (last menstruation <= 1 year prior to informed consent) who:
- are nursing or pregnant or
- are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner
13. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
14. Participation in another trial with an investigational drug within 30 days prior to informed consent
15. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial



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

Health Condition(s) or Problem(s) studied

Patients with type 2 diabetes mellitus.
MedDRA version: 14.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Intervention(s)

Product Name: BI 10773
Product Code: BI 10773
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BI 10773
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: BI 10773
Product Code: BI 10773
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BI 10773
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Januvia
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SITAGLIPTIN
CAS Number: 790712-60-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 (10 and 25 mg once daily) compared to placebo and sitagliptin (100 mg once daily) given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control.

For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.

Secondary Objective:

Primary end point(s): The primary endpoint in this study is the change from baseline in HbA1c after 24 weeks of treatment (%). Throughout the study protocol, the term "baseline" refers to the last observation prior to the administration of any (open-label 25 mg BI 10773 or randomised) study medication.

Secondary ID(s)

1245.20

Ethics review

Status: Approved
Approval date: 26/10/2010
Contact:

Results

• Results available: Yes
• Date Posted: 15/07/2016
• Date Completed: 19/03/2012
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-016243-20/results