Trials / Completed
CompletedNCT03414892
Multiple Ascending Doses of Globalagliatin Hydrochloride in Type 2 Diabetes Mellitus
A Phase I Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Globalagliatin Hydrochloride After Multiple Ascending Doses in Patients With Type 2 Diabetes Mellitus
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Yabao Pharmaceutical Group · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase I placebo-controlled study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of Globalagliatin Hydrochloride (SY-004) after Multiple Ascending Doses in patients with Type 2 Diabetes Mellitus (T2DM).
Detailed description
Glucokinase is a characteristic hexokinase isoenzyme in hepatocytes that catalyzes the first step in glucose metabolism. In addition to its role in glucose metabolism, glucokinase is expressed in pancreatic islet beta cells where it acts as a "glucose sensor" for insulin release. Activation of glucokinase increases the glucose sensitivity of insulin secretion, effectively lowering the glucose threshold for insulin secretion. Because of its potential to enhance insulin secretion and affect hepatic glucose metabolism, is being investigated for use as a treatment for hyperglycaemia, Globalagliatin( the active ingredient in SY-004 capsule) is being investigated for use as a treatment for T2DM patients. This is a phase I placebo-controlled study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of Globalagliatin Hydrochloride (SY-004) after Multiple Ascending Doses in patients with Type 2 Diabetes Mellitus.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Globalagliatin Hydrochloride | once daily, oral |
| DRUG | Placebo | once daily, oral |
Timeline
- Start date
- 2018-01-03
- Primary completion
- 2019-01-04
- Completion
- 2019-12-01
- First posted
- 2018-01-30
- Last updated
- 2020-01-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03414892. Inclusion in this directory is not an endorsement.