- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05386186
The Effect of Glimepiride Compared With Sitagliptin as an add-on Therapy to Metformin in Severe Insulin Deficiency Diabetes
May 18, 2022 updated by: Xiantong Zou, MD. Ph.D., Peking University People's Hospital
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
192
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiantong Zou, MD.Ph.D.
- Phone Number: 13370172042
- Email: eva2172@163.com
Study Locations
-
-
Please Select
-
Beijing, Please Select, China, 100044
- Recruiting
- Peking University People's Hospital
-
Contact:
- Xiantong Zou
- Phone Number: 88324371
- Email: eva2172@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
- Men and women aged ≥ 18 years and ≤ 75 years;
- Diagnosed as severe insulin deficiency diabetes by the cluster classifier of Peking University People's Hospital at the initial stage of the disease course;
- Metformin monotherapy with dosage ≥1500 mg/day for at least 8 weeks;
- Diabetes duration less than 5 years;
- The HbA1c value of the central laboratory before randomization: 7.0% ≤ HbA1c <10.5%
- estimated estimated glomerular filtration rate (eGFR)>=60 ml/min1.73m2, alanine aminotransferase(ALT)<120U/L ;
- If other drugs are used during the course of the disease, these drugs should be withdrawn for more than 8 weeks;
- Without acute diabetic complications at present.
Exclusion Criteria:
- 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.
- Pregnancy or have a pregnancy plan within a year;
- Lactation or have a lactation plan within a year;
- Renal insufficiency, eGFR<60; transaminase elevated, ALT>= 120U/L; unstable coronary heart disease.
- Recurrent spontaneous diabetic ketosis or uncorrected acute diabetic complications;
- 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.
- Use concomitant medication such as glucocorticoids which can affect blood sugar.
- The investigator judged that it is not suitable to participate in this clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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:
|
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.
|
Add sitagliptin 100mg once daily in all patients randomized to this arm.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of hemoglobin A1c from baseline at the end of the trial.
Time Frame: 26 weeks
|
The Least squre mean of the decline of hemoglobin A1c from baseline to the end of the trial
|
26 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin A1c on-target rate
Time Frame: 26 weeks
|
the percentage of A1c<7.0%
or A1c<6.5%
|
26 weeks
|
The difference of self measure blood glucose (SMBG) at every month
Time Frame: for 26 weeks
|
The mean of 4-point SMBG for every four weeks
|
for 26 weeks
|
The incidence rate of hypoglycemia
Time Frame: for 26 weeks
|
Any measurement of blood glucose<3.9mmol/L
or symptoms related to hypoglycemia
|
for 26 weeks
|
The level of weight gain
Time Frame: for 26 weeks
|
The difference between body weights at the beginning and end of the trial
|
for 26 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiantong Zou, M.D. Ph.D., Peking University People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Anticipated)
October 31, 2023
Study Completion (Anticipated)
March 31, 2024
Study Registration Dates
First Submitted
May 12, 2022
First Submitted That Met QC Criteria
May 18, 2022
First Posted (Actual)
May 23, 2022
Study Record Updates
Last Update Posted (Actual)
May 23, 2022
Last Update Submitted That Met QC Criteria
May 18, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Enzyme Inhibitors
- Immunosuppressive Agents
- Immunologic Factors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Sitagliptin Phosphate
- Glimepiride
- Dipeptidyl-Peptidase IV Inhibitors
Other Study ID Numbers
- zhouxiantong
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
AstraZenecaNot yet recruiting
Clinical Trials on Glimepiride
-
Dong-A ST Co., Ltd.CompletedType2 DiabetesKorea, Republic of
-
GlaxoSmithKlineCompletedDiabetes Mellitus, Type 2Korea, Republic of, Malaysia, Philippines, Thailand, Russian Federation, Mexico
-
IKFE Institute for Clinical Research and DevelopmentCompletedType 2 Diabetes Mellitus | Insulin ResistanceGermany
-
Laboratorios Silanes S.A. de C.V.CompletedEffect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes MellitusType 2 Diabetes MellitusMexico
-
Laboratorios Silanes S.A. de C.V.Recruiting
-
GlaxoSmithKlineTerminatedDiabetes Mellitus, Type 2China
-
SanofiCompleted
-
SanofiCompleted
-
LG Life SciencesUnknownType 2 Diabetes MellitusKorea, Republic of
-
Kyunghee University Medical CenterSanofi; Korea University Guro Hospital; Hanyang University; The Catholic University... and other collaboratorsCompletedType 2 Diabetes Mellitus | Pancreatic Beta Cell Function | GlucotoxicityKorea, Republic of