A phase III randomised, double-blind, active-controlled parallel group efficacy and safety study of BI 10773 compared to glimepiride administered orally during 104 weeks with a 104-week extension period in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin treatment

Phase 3

Completed

Conditions: diabetes
Diabetes mellitus type 2
10018424

Registration Number: NL-OMON38357

Lead Sponsor: Boehringer Ingelheim

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

(see paragraph 3.3.2 of the protocol for the complete list)
1. Diagnosis of type 2 diabetes mellitus prior to informed consent
2. Male and female patients on diet and exercise regimen who are
pre-treated with immediate release metformin unchanged for 12 weeks prior to
randomisation. Minimum dose for metformin: > <= 1500 mg/day or maximum tolerated
dose (the investigator must have documented the reason why up-titration to ><= 1500
mg/day was not possible) or maximum dose according to local label.
3. HbA1c of *7.0% and * 10% at Visit 1
4. Age * 18yrs
5. BMI * 45 kg/m2 (Body Mass Index) at Visit 1
6. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and
local legislation

Exclusion Criteria

(see paragraph 3.3.3 of the protocol for the complete list)
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 after an
overnight fast using another device (not on the same day).
2. Any other antidiabetic drug within 12 weeks prior to randomisation except immediate release metformin
3. Acute coronary syndrome (non-STEMI, STEMI, unstable AP) Stroke or TIA within 3
months prior to informed consent.
4. 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) as determined at Visit 1
5. Impaired renal function, defined as eGFR<60 ml/min (moderate to severe renal impairment using MDRD formula)
6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
8. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia)
9. Contraindications including hypersensitivity known to metformin or sulfonylureas according to the local label
10. Treatment with anti-obesity drugs 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. (Treatment with local and inhaled steroids is allowed)
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 practising 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. Intake of an investigational drug in another trial within 30 days prior to intake of
study medication in this trial.
15. Any other clinical condition that would jeopardize patients safety while participating in
this clinical trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Change from baseline in HbA1c after 52 weeks and 104 weeks of treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Change in body weight from baseline after 52 weeks and 104 weeks of treatment.<br /><br>- Occurrence of confirmed syptomatic hypoglycaemic events during 52 weeks and<br /><br>104 weeks of treatment.<br /><br>- Changes in blood pressure (SBP and DBP) from baseline, after 52 weeks and 104<br /><br>weeks of treatment.</p><br>

Updated 4/15/2024

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