Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this studay is to compare the efficacy of different hypoglycemic regimens versus twice-daily premixed insulin in type 2 diabetes mellitus (T2DM) patients after short-term ntensive Insulin Therapy by using continuous glucose monitoring.
Detailed description
This randomized, positive-controlled, open-label, parallel-group study will enroll approximately 78 male and female patients aged 18-70 years with poorly-controlled T2DM (HbA1c \>9% or FBS\>11.1mmol/L) after short-term intensive insulin therapy. Eligible patients will then be randomized in a 1:1:1 ratio to insulin glargine plus OADs or twice-daily premixed insulin or Insulin Degludec & Liraglutide for 3 months with metformin maintained throughout the study in both treatment groups. All the patients will wear CGM during short-term intensive insulin therapy and after treatment for 7 days. The primary endpoint is plasma glucose change from baseline to month 3. Secondary endpoints include assessment of fasting plasma glucose, total daily insulin dose, hypoglycemia incidence, body weight change, adverse events, and patient satisfaction.
Interventions
DRUGmetformin+empagliflozin+insulin glargine
Randomization was performed with the use of a computer-generated system provided by the sponsor. The dose of metformin will be initiated at 0.5 grams three times a day (the maximum dose is 2g/day); the dose of empagliflozin will be 10 milligrams once a day; insulin glargine will be received once daily at bedtime and the dose will be initiated at the 50% of 0.4-0.5 units/kg/day. All groups received counseling on lifestyle modification.
DRUGIDegLira
Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients will be initiated on 16 units (16 units degludec/0.58 mg liraglutide) and titrated twice weekly. The maximum dose of IDegLira was 50 units (50 units degludec/1.8 mg liraglutide). All groups received counseling on lifestyle modification.
DRUGpremixed insulin analogues
Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients will received twice a day. The total daily insulin dose will be initiated at 0.4-0.5 units/kg/day and adjusted according to the plasma glucose. All groups received counseling on lifestyle modification.
Sponsors
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* aged 18-70 years with poorly-controlled T2DM (World Health Organization diagnostic criteria) * BMI 21\ 32Kg/m2 * duration of T2DM more than 1 year * FPG≥11.1mmol/L or HbA1c ≥9% for three months * fasting C-peptide \>1 ng/mL
Exclusion criteria
* acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic diabetic coma) within the past 1 month; * impaired renal function,defined as (but not limited to) serum creatinine levels ≥1.5 mg/dL for males and ≥1.4 mg/dL for females, or the presence of macroproteinuria (\> 2 g/day) * pregnancy * inability to perform self-monitoring of BG (SMBG) * acute disease or surgery in the past 3months or preparation for the surgey
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in HbA1c | Month 0 to 3 | mean change from baseline in HbA1c after 3-months of treatment. |
| Percentage of patients achieving HbA1c <7% | Month 0 to 3 | Percentage of patients achieving HbA1c \<7% after 3-months of treatment. |
| Amplitude of glycemic excursions | Month 0 to 3 | Amplitude of glycemic excursions from month 0 to 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of hypoglycemia incidence | Month 0 to 3 | Percentage of hypoglycemia incidence from month 0 to 3 |
| Percentage of adverse events | Month 0 to 3 | Percentage of adverse events from month 0 to 3 |
Countries
China
Contacts
Primary ContactJing Wu
Outcome results
None listed