Study of Efficacy, Weight Control, and Safety in Newly-diagnosed Type 2 Diabetes With Different Antidiabetic Therapy

NCT03700801 | Completed Phase 4

• 1 other identifier: 2018-NFMDXK-003
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Study Hypothesis：Compared with premixed insulin, triple oral combination therapy has similar hypoglycemic effect, better weight control and lower incidence of hypoglycemia. Main objective: Comparing whether the hypoglycemic efficacy of the triple oral combination therapy is not inferior than that of the premixed insulin in the treatment of newly-diagnosed type 2 diabetes. Secondary objective: Comparing the effects on body weight and the risk of inducing hypoglycemia between triple oral combination therapy and premixed insulin, and exploring the effects of these two therapies on weight control and safety. Primary Study Endpoint: The absolute change in baseline of HAb1c after 12 weeks. Secondary Study Endpoint: fasting blood glucose, 2-hour postprandial blood glucose, fasting C-peptide, 2-hour postprandial C-peptide, body weight, proportion of patients with hypoglycemia, etc.

Conditions

Type 2 Diabetes Mellitus

Keywords

Triple Combination Therapy; Premixed Insulin; Hypoglycemic efficacy; Weight control; Safety

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Changes in HbA1c after 12 weeks of intervention.

  12 weeks

Secondary Outcomes (4)

• fasting/2-hour postprandial blood glucose

  12 weeks

• Fasting/2-hour postprandial c-peptide

  12 weeks

• Weight

  12 weeks

• Rate of hypoglycemia

  12 weeks

Study Arms (2)

Triple combination therapy group

EXPERIMENTAL

triple combination therapy group: Triple oral hypoglycemic therapy based on metformin 0.5mg twice a day, dapagliflozin 10mg per day plus saxagliptin 5mg per day.

Drug: Triple combination therapy group

Premixed insulin therapy group

ACTIVE COMPARATOR

premixed insulin therapy group: The initial total dose is 0.3U-0.5U/Kg, twice a day, subcutaneous injection before breakfast and dinner, adjusted according to the blood glucose level detected by the blood glucose meter

Drug: Premixed insulin therapy group

Interventions

Triple combination therapy group DRUG

Triple oral hypoglycemic therapy based on metformin, dapagliflozin plus saxagliptin.

Also known as: Metformin, Dapagliflozin and Saxagliptin

Triple combination therapy group

Premixed insulin therapy group DRUG

Subcutaneous injection therapy with insulin aspart 30 in patients with T2DM

Also known as: Insulin aspart 30

Premixed insulin therapy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The newly-diagnosed type 2 diabetes mellitus according to the 1999 WHO guideline on diagnosing type 2 diabetes mellitus; 9%≤HbA1c≤12%;
• Age: 18-65 years old, Men or women;
• Voluntarily taking the triple combination therapy using metformin, saxagliptin plus dapagliflozin or premixed insulin therapy, without taking any other hypoglycemic therapy before;
• kg/m2≦BMI≦32 kg/m2;
• Voluntarily participating in our study and insisting on monitoring blood glucose at least one day a week, finishing re-examination after three month with the informed consent signed.

You may not qualify if:

• Type 1 diabetes mellitus, or islet dysfunction (fasting C-peptide \<0.1nmol/L (0.3ng/ml), peak value \<0.17nmol/L (0.5ng/ml))
• Patients with acute complication：ketoacidosis / hyperglycemic hyperosmolar status / lactic acidosis.
• Patients with proliferative diabetic retinopathy.
• Patients with severe infection or urinary tract infection.
• Patients with clinically significant hepatobiliary disorders, including but not limited to chronic active hepatitis and / or severe liver dysfunction. ALT or AST\> 3 times the normal upper limit (ULN) or serum total bilirubin (TB)\> 34.2 μmol / L (\> 2 mg / dL).
• Patients with the following nephrotic history or kidney disease-related characteristics：
• history of unstable or acute kidney disease;
• Patients with moderate / severe renal injury or end-stage renal disease (eGFR \<60 mL / min / 1.73 m2)
• urinary albumin: creatinine ratio\> 1800 mg / g;
• the serum (Cr) ≥133 μmol / L (≥1.50 mg / dL) in male subjects; the serum Cr≥124μmol / L (\> 1.40 mg / dL) in female subjects;
• congenital renal glucosuria;
• Poor control of Severe hypertension, SBP ≥ 160 mmHg and / or DBP ≥ 100 mmHg; SBP \<96 mmHg;
• Patients with myocardial infarction / unstable angina / severe arrhythmia / heart failure in the past 3 months;
• Hb≤110g/L in female subjects and Hb≤120g/L in male subjects;
• Pregnant women or women who are planning to be pregnant during the study, women who are currently in lactation, or who having not adopted highly effective, medical-approved birth control methods.

Sponsors & Collaborators

• Zhujiang Hospital: lead
• The Sixth Affiliated Hospital of Guangzhou Medical University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Peking University Shenzhen Hospital: collaborator
• Dongguan Kanghua Hospital: collaborator
• First People's Hospital, Shunde China: collaborator
• The First Affiliated Hospital of Guangdong Pharmaceutical University: collaborator
• The Fifth Affiliated Hospital of Zunyi Medical College: collaborator
• Shenzhen Sixth People's Hospital: collaborator

Study Sites (1)

The Pearl River Hospital of Southern Medical University

Guangzhou, Guangdong, 510300, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; dapagliflozin; saxagliptin; insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jia Sun

  Department of Endocrinology, Zhujiang Hospital, Southern Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: According to two different therapies, patients were divided into the study group (triple combination therapy group) and control group (premixed insulin treatment group). Each group included 65 cases.

Study Record Dates

• First Submitted: September 9, 2018
• First Posted: October 9, 2018
• Study Start: October 1, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: March 18, 2024

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)