HSK7653 Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the efficacy of HSK7653 (as an add-on to metformin) compared with linagliptin after 24 weeks, and the safety (up to 52 weeks) of HSK7653 in Chinese patients with Type 2 Diabetes who have inadequate glycemic control on diet/exercise therapy and metformin agent monotherapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The treatment period is composed of a 24-week double-blind period (week 1-24) and a 28-week open-label period (week 25-52). During the double-blind period, participants will receive 10 mg or 25 mg dose of HSK7653, or linagliptin, and with matching placebo respectively. During the open-label period, all participants will receive 25 mg dose of HSK7653. All participants will receive a stable dose of metformin therapy in both the double-blind period and the open-label period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HSK7653 10 mg
|
Drug: HSK7653 10 mg Q2W
HSK7653 5 mg (2 tablets) and placebo 25 mg (1 tablet) Q2W, placebo of linagliptin 5 mg QD, oral, week 1 to week 24; HSK7653 25 mg Q2W, oral, week 25 to week 52.
|
| Experimental: HSK7653 25 mg
|
Drug: HSK7653 25 mg Q2W
HSK7653 25 mg (1 tablet) and placebo 5 mg (2 tablets) Q2W, placebo of linagliptin 5 mg QD, oral, week 1 to week 24; HSK7653 25 mg (1 tablet) Q2W, oral, week 25 to week 52.
|
| Active Comparator: Linagliptin 5 mg
|
Drug: Linagliptin 5 mg QD
Linagliptin 5 mg QD, placebo of HSK7653 25 mg (1 tablet) and 5 mg (2 tablets) Q2W, oral, week 1 to week 24; HSK7653 25 mg Q2W, oral, week 25 to week 52.
|
Outcome Measures
Primary Outcome Measures
- HbA1c Change From Baseline at Week 24 [Baseline and week 24]
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Secondary Outcome Measures
- Incidence of Treatment-Emergent Adverse Events [Baseline, week 24 and week 52]
The incidence of Treatment-Emergent Adverse Events over time (at week 24 and week 52)
- Percentage of Patients With HbA1c <7.0% [Baseline, week 24 and week 52]
- Percentage of Patients With HbA1c <6.5% [Baseline, week 24 and week 52]
- FPG Change From Baseline at Week 24 and Week 52 [Baseline , week 24 and week 52]
- 2h-PPG Change From Baseline at Week 24 and Week 52 [Baseline, week 24 and week 52]
- Weight Change From Baseline at Week 24 and Week 52 [Baseline, week 24 and week 52]
- Fasting C-peptide Change From Baseline at Week 24 and Week 52 [Baseline, week 24 and week 52]
- Insulin Sensitivity Change (Calculated by HOMA-IS) From Baseline at Week 24 and Week 52 [Baseline, week 24 and week 52]
- Pancreatic β-cell function Change (Calculated by HOMA-β) From Baseline at Week 24 and Week 52 [Baseline, week 24 and week 52]
- Percentage of Patients Required Use of Rescue Therapy or Dropout due to Hyperglycemia and Week 52 [Baseline, week 24 and week 52]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18 and ≤ 75 years, Male and female patients;
-
Type 2 diabetes mellitus;
-
Insufficient glycaemic control with diet/exercise therapy and metformin agent monotherapy;
-
Did not receive regular long-term medication of oral hypoglycemic drugs (except metformin) or insulin within 1 year prior to informed consent;
-
HbA1c in the range of ≥7.5 to ≤11.0% at screening;
-
FPG < 15 mmol/L at screening;
-
BMI (Body Mass Index) in the range of ≥ 18.0 kg/m² to ≤ 35.0 kg/m² at screening.
Exclusion Criteria:
-
Diabetic ketoacidosis, hyperglycemia hypertonic state, serious complications of diabetes, myocardial infarction, stroke within 6 months prior to informed consent;
-
History of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent;
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Current hemoglobinopathy, uncontrolled hypertension, serious nephropathy or hepatopathy prior to informed consent;
-
Serious gastrointestinal disease within 2 weeks prior to informed consent;
-
Serious infection, trauma, and surgery within 3 months prior to informed consent;
-
History of treatment with Dipeptidyl-Peptidase 4 (DPP-4) inhibitor, Glucose-dependent insulinotropic polypeptide (GIP) or Glucagon-like peptide-1 (GLP-1) receptor agonist;
-
Treatment with drugs that affect glucose metabolism within 8 weeks prior to informed consent;
-
Hemoglobin (HGB) < 10.0 g/dL(100 g/L);
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Alcohol abuse within 6 months or drug abuse history within 5 years prior to informed consent;
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Active infectious diseases;
-
Participation in another trial with an investigational drug or instrument within 3 months prior to informed consent;
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Women who are nursing or pregnant, or subjects who have planned parenthood;
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Contraindication for empagliflozin or linagliptin;
-
Other protocol-defined inclusion/exclusion criteria.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University People's Hospital | Beijing | Beijing | China | 100044 |
| 2 | Inner Mongolia Baogang Hospital | Baotou | Inner Mongolia | China |
Sponsors and Collaborators
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSK7653-302
- CTR20201724