The Effect of Glimepiride Compared With Sitagliptin as an add-on Therapy to Metformin in Severe Insulin Deficiency Diabetes
Study Details
Study Description
Brief Summary
The purpose of the trial is to verify the effectiveness and safety of glimepiride compared with sitagliptin as an add-on therapy to metformin in severe insulin deficiency diabetes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
This clinical trial is a multi-centre, prospective, intervention, randomized-controlled clinical trial, and uses a superiority test to determine whether the experimental group is superior to the control group in terms of main efficacy endpoints.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Glimepiride All participants have background therapy of metformin 1500mg-2000mg, glimepiride1-4mg were added in the patients randomised to this arm considering the baseline HbA1c of the participants. |
Drug: Glimepiride
Initiate glimepiride 1-4mg once daily as an add-on therapy to metformin and adjust the glimepiride dosage to 1-6 mg once daily in the first 12 weeks according to the diabetes management guideline recommended by the Chinese Diabetes Society.
Other Names:
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| Active Comparator: Sitagliptin All participants have background therapy of metformin 1500mg-2000mg, Sitagliptin 100mg were added in the patients randomised to this arm regardless of the baseline HbA1c level in this arm. |
Drug: Sitagliptin
Add sitagliptin 100mg once daily in all patients randomized to this arm.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Reduction of hemoglobin A1c from baseline at the end of the trial. [26 weeks]
The Least squre mean of the decline of hemoglobin A1c from baseline to the end of the trial
Secondary Outcome Measures
- Hemoglobin A1c on-target rate [26 weeks]
the percentage of A1c<7.0% or A1c<6.5%
- The difference of self measure blood glucose (SMBG) at every month [for 26 weeks]
The mean of 4-point SMBG for every four weeks
- The incidence rate of hypoglycemia [for 26 weeks]
Any measurement of blood glucose<3.9mmol/L or symptoms related to hypoglycemia
- The level of weight gain [for 26 weeks]
The difference between body weights at the beginning and end of the trial
Eligibility Criteria
Criteria
Inclusion Criteria:
-
According to the World Health Organization (the WHO) 1999 criteria for the diagnosis of type 2 diabetes; the subtype was allocated to severe insulin deficiency diabetes (SIDD) at diagnosis using data-driven diabetes clusters APP.
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Men and women aged ≥ 18 years and ≤ 75 years;
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Diagnosed as severe insulin deficiency diabetes by the cluster classifier of Peking University People's Hospital at the initial stage of the disease course;
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Metformin monotherapy with dosage ≥1500 mg/day for at least 8 weeks;
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Diabetes duration less than 5 years;
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The HbA1c value of the central laboratory before randomization: 7.0% ≤ HbA1c <10.5%
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estimated estimated glomerular filtration rate (eGFR)>=60 ml/min1.73m2, alanine aminotransferase(ALT)<120U/L ;
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If other drugs are used during the course of the disease, these drugs should be withdrawn for more than 8 weeks;
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Without acute diabetic complications at present.
Exclusion Criteria:
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Type 1 diabetes or other special types of diabetes mellitus; glutamic acid decarboxylase antibody (GADA) positive, the subtype was allocated to other subtypes at diagnosis using data-driven diabetes clusters APP.
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Pregnancy or have a pregnancy plan within a year;
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Lactation or have a lactation plan within a year;
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Renal insufficiency, eGFR<60; transaminase elevated, ALT>= 120U/L; unstable coronary heart disease.
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Recurrent spontaneous diabetic ketosis or uncorrected acute diabetic complications;
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Participated in other clinical trials within 8 weeks before randomization; Unable to complete the study follow-up for 6 months; Have situations such as operation and need to change to insulin therapy in 6 months.
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Use concomitant medication such as glucocorticoids which can affect blood sugar.
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The investigator judged that it is not suitable to participate in this clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University People's Hospital | Beijing | Please Select | China | 100044 |
Sponsors and Collaborators
- Peking University People's Hospital
- Peking University First Hospital
- Jiangsu Province Geriatric Institute
Investigators
- Principal Investigator: Xiantong Zou, M.D. Ph.D., Peking University People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- zhouxiantong