Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes
Verified date | January 2018 |
Source | Adocia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.
Status | Completed |
Enrollment | 32 |
Est. completion date | December 21, 2017 |
Est. primary completion date | August 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Male or female subject aged 18-70 years (both inclusive) - Type 2 diabetes mellitus (as diagnosed clinically) for = 12 months - HbA1c level between 6.5% and 9.0 % (both inclusive) - Body mass index between 20.0 and 40.0 kg/m2 (both inclusive) - Body weight <= 125.0 kg at the screening visit - Insulin-treated subjects. Total insulin dose of <= 1.2 (I)U/kg/day Exclusion Criteria: - Type 1 diabetes mellitus - Known or suspected hypersensitivity to IMP(s) or related products - Previous participation in this trial. Participation is defined as randomised. - Receipt of any medicinal product in clinical development within 60 days before randomisation in this trial. - Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator considering the underlying disease. - Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the range of 90-160 mmHg systolically or 50-95 mmHg diastolically (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial); symptoms of arterial hypotension and/or a heart rate at rest outside the range of 50-90 beats per minute. This exclusion criterion also pertains to subjects being on anti-hypertensives. - Women of child bearing potential not willing to use contraceptive methods. |
Country | Name | City | State |
---|---|---|---|
Germany | Profil Mainz GmbH & Co. KG | Mainz | |
Germany | Profil Institut für Stoffwechselforschung GmbH | Neuss |
Lead Sponsor | Collaborator |
---|---|
Adocia |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AUC last_total | Area under the plasma insulin concentration-time curve from t=0 to the last measured total insulin plasma concentration above LLOQ. The total insulin concentration is the sum of lispro and basal concentrations. | From 0 to 30 hours | |
Primary | Cmax_total | Maximum observed plasma insulin total concentration | From 0 to 30 hours | |
Secondary | AUCGIR 0-last (mg/kg) | Area under the glucose infusion rate curve from 0 hours until the end of clamp | From 0 to 30 hours | |
Secondary | GIRmax (mg/kg/min) | Maximum glucose infusion rate | From 0 to 30 hours | |
Secondary | tGIRmax | Time to maximum glucose infusion rate | From 0 to 30 hours | |
Secondary | Adverse Events | Up to 102 days (maximum duration of subject's participation) | ||
Secondary | Local tolerability: number of injection site reaction | Frequency of injection site reaction in each arm. | Up to 102 days (maximum duration of subject's participation) | |
Secondary | Number of hypoglycaemic events in each treatment arm | Up to 102 days (maximum duration of subject's participation) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02771093 -
An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus
|
Phase 4 | |
Completed |
NCT02545842 -
Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)
|
Phase 4 | |
Recruiting |
NCT03436212 -
Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump.
|
N/A | |
Completed |
NCT03244800 -
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
|
Phase 2 | |
Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
Withdrawn |
NCT02769091 -
A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes
|
Phase 2 | |
Recruiting |
NCT06065540 -
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
|
Phase 3 | |
Recruiting |
NCT05008276 -
Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
|
||
Completed |
NCT04091373 -
A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide
|
Phase 1 | |
Completed |
NCT03296800 -
Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT06212778 -
Relationship Between Nutritional Status, Hand Grip Strength, and Fatigue in Hospitalized Older Adults With Type 2 Diabetes Mellitus.
|
||
Completed |
NCT05979519 -
Fresh Carts for Mom's to Improve Food Security and Glucose Management
|
N/A | |
Recruiting |
NCT05579314 -
XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
Terminated |
NCT03684642 -
Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
|
Phase 3 | |
Completed |
NCT03248401 -
Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT03644134 -
A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns
|
N/A | |
Completed |
NCT05295160 -
Fasting-Associated Immune-metabolic Remission of Diabetes
|
N/A | |
Completed |
NCT02836873 -
Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment
|
Phase 3 | |
Completed |
NCT02252224 -
Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance
|