Trial record 1 of 1 for:
NCT03297879
Comparison of Exenatide and Metformin Monotherapy in Overweight/Obese Patients With Newly Diagnosed Type 2 Diabetes
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03297879 |
|
Recruitment Status :
Completed
First Posted : September 29, 2017
Last Update Posted : October 2, 2017
|
Sponsor:
Beijing Chao Yang Hospital
Information provided by (Responsible Party):
Guang Wang, Beijing Chao Yang Hospital
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The present study assessed the therapeutic effect of exenatide and metformin as the initial therapy in overweight/obese patients with newly diagnosed Type 2 diabetes (T2D).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type2 Diabetes | Drug: Exenatide or metformin hydrochloride | Phase 4 |
The present study was a prospective, nonrandomized, interventional study.The drug-naïve, overweight or obese patients with newly diagnosed T2D were consecutively enrolled. The inclusion criteria: 1) age 20 - <65 years, 2) body mass index (BMI) ≥ 24 kg/m2 [7], and 3) HbA1c ≥ 7% (53mmol/mol). An oral glucose tolerance test was performed during the screenings. All of the patients have no diabetes antibodies and were diagnosed with T2D within the previous 3 months, according to the ADA diagnostic criteria. None of the patients had administered anti-diabetic drugs or diet therapy before participation. Neither of the patients presented any history of pancreatitis, coronary artery disease, liver function impairment, renal function impairment, intestinal surgery, chronic hypoxic diseases (emphysema and cor pulmonale), infectious disease, hematological disease, systemic inflammatory disease, or cancer. Patients who were pregnant, possibly pregnant, or ingesting agents known to influence glucose or lipid metabolism were also excluded.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 230 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Beijing Chao-Yang Hospital, Capital Medical University |
| Actual Study Start Date : | January 1, 2013 |
| Actual Primary Completion Date : | February 28, 2016 |
| Actual Study Completion Date : | February 28, 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
| Arm | Intervention/treatment |
|---|---|
|
Experimental: exenatide group
The drug-naïve, overweight or obese patients with newly diagnosed T2D
|
Drug: Exenatide or metformin hydrochloride
Exenatide was administrated with 5 μg bid for 4 weeks and 10 μg bid for 8 weeks. Metformin hydrochloride was initiated at a dose of 500 mg bid for 2 weeks, and added to 2.0 g/day for 8 weeks. |
|
Active Comparator: metformin group
The drug-naïve, overweight or obese patients with newly diagnosed T2D
|
Drug: Exenatide or metformin hydrochloride
Exenatide was administrated with 5 μg bid for 4 weeks and 10 μg bid for 8 weeks. Metformin hydrochloride was initiated at a dose of 500 mg bid for 2 weeks, and added to 2.0 g/day for 8 weeks. |
Primary Outcome Measures :
- The change of HbA1c [ Time Frame: baseline and 12 weeks ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 20 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age 20 - <65 years,
- body mass index (BMI) ≥ 24 kg/m2,
- HbA1c ≥ 7% (53mmol/mol).
- diabetes antibodies (-)
- diagnosed with T2D within the previous 3 months
Exclusion Criteria:
- anti-diabetic drugs or diet therapy before participation
- pancreatitis
- coronary artery disease
- liver function impairment
- renal function impairment
- intestinal surgery
- chronic hypoxic diseases (emphysema and cor pulmonale)
- infectious disease
- hematological disease
- systemic inflammatory disease
- cancer
- pregnant, possibly pregnant
- ingesting agents known to influence glucose or lipid metabolism
No Contacts or Locations Provided
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Guang Wang, Director of Endocrinology,Principal Investigator, Beijing Chao Yang Hospital |
| ClinicalTrials.gov Identifier: | NCT03297879 |
| Other Study ID Numbers: |
2015-科 144 |
| First Posted: | September 29, 2017 Key Record Dates |
| Last Update Posted: | October 2, 2017 |
| Last Verified: | September 2017 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin Exenatide |
Hypoglycemic Agents Physiological Effects of Drugs Anti-Obesity Agents Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |