KBP-042 in Type 2 Diabetes
Research type
Research Study
Full title
A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-042 in Patients with Type 2 Diabetes
IRAS ID
230449
Contact name
Veronika Horvathova
Contact email
Sponsor organisation
KeyBioscience AG
Eudract number
2017-001061-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 0 days
Research summary
Type 2 diabetes (T2DM) is a disease characterised by abnormally high sugar (glucose) levels in the blood. If not adequately treated, T2DM is associated with a high risk of cardiovascular disease and other serious complications.
Overweight or obesity in itself is associated with imbalance in blood glucose levels and T2DM occurs often in overweight and obese people.
KBP-042 is a synthetically produced molecule that is injected under the skin. This drug aims at controlling glucose levels and insulin sensitivity, as well as reducing body weight. Previous clinical studies in humans have indicated that KBP-042 is likely to have a beneficial effect in obese T2DM patients by not only regulating glucose levels, but also energy balance and body weight.
This study will recruit a total of 240 T2DM subjects who are taking only metformin, and who require additional medication to better control their glucose levels. The 12-week treatment period will be sufficient to demonstrate the efficacy levels of three different dose levels of KBP-042 (against placebo) using the internationally recognised HbA1c blood test as the primary outcome criterion.
Subjects will attend the clinic a maximum of 11 times over the 14-week study period.REC name
London - South East Research Ethics Committee
REC reference
17/LO/1136
Date of REC Opinion
17 Aug 2017
REC opinion
Further Information Favourable Opinion