A Cohort Study of Incretin-based Therapy Combined With Insulin in Type 2 Diabetic Patients for 5 Years
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01681550|
Recruitment Status : Not yet recruiting
First Posted : September 10, 2012
Last Update Posted : September 11, 2012
The use of dipeptidyl-peptidase 4 (DPP-4) inhibitors and glucagon like peptide 1 (GLP1) analogues for the treatment of diabetic mellitus (DM) type 2 is growing (1,2). Currently, some of these agents have been approved in combination with insulin. The potential for combined use with insulin has garnered increasing attention due to reduce side effects associated with insulin therapy and improve glycemic control. Some investigators reported that GLP-1 analogue combined with insulin reduces HbA1c and weight with low risk of hypoglycemia and high treatment satisfaction (3). However, their duration of treatment was short time with less than a mean of 3.0 years and the alterations of chronic diabetic complications by combination with incretin-based and insulin therapies are not known.
We evaluated the long effects of adding incretin-based therapy (DPP-4 inhibitors or GLP-1 analogues) to insulin therapy on glycated hemoglobin (HbA1c) as glycemic control, body mass index (BMI), blood pressure (BP), insulin dosage, frequency of hypoglycemia, and chronic diabetic complications for 5 years-treatments.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Incretin-based therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Incretin-based Therapy Combined With Insulin on HbA1c, Hypoglycemia and Chronic Diabetic Complications in Type 2 Diabetic Patients|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
|Incretin theapy combined with insulin||
Drug: Incretin-based therapy
- Death [ Time Frame: Duration varied between individual patients and was as the period of time after treatment with incretin-based therapy combined with insulin. ]The cause of death was determined by attending doctor or was assessed by interviewing the family.
- HbA1c [ Time Frame: Average time requires 5 years ]Duration varied between individual patients and was as the period of time until after treatment with incretin-based therapy combined with insulin.
- BMI [ Time Frame: Average time requires 5 years ]BMI was calculated from body weight and height for at baseline and every 3 to 6 months throughout the study.
- Blood pressure [ Time Frame: Average time requires 5 years ]Participants were examined using the same methods reported previously (4). Briefly, BP was measured in the clinic and at home on waking in the morning at trough by the same methods included device, device validation, observer, number of measurements, conditions, posture and cuffs described previously (4). Namely, clinic BP (CBP) was measured once in each clinic visit. Home BP (HBP) was measured every day in the morning within 10 minutes after awakening in the sitting position.
- Insulin dose [ Time Frame: Average time requires 5 years ]Patients were treated with insulin analogues using MDI, or twice-daily injections. The dose was estimated by medical records.
- Hypoglycemia [ Time Frame: Average time requires 5 yearsinsulin. ]Patients were treated with insulin analogues using MDI, or twice-daily injections. The dose was estimated by medical records.
- Hypoglycemia [ Time Frame: Average time requires 5 years ]Hypoglycemia and the number of time per day were assessed by medical examination owing to interview.
- Microvascular complications including renal anemia [ Time Frame: Average time requires 5 years ]They were assessment by the method mentioned above. As renal anemia, serum hemoglobin (Hb) was measured by cyanmet-hemoglobin method using commercial reagent.
- Macrovasular complications [ Time Frame: Average time requires 5 years ]They were confirmed by medical history, including contents of treatment. New or worsened (recurrent) events were defined based on clinical manifestations and treatment throughout the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681550
|Contact: Kyuzi Kamoi, MDfirstname.lastname@example.org|
|Nagaoka Red Cross Hospital||Not yet recruiting|
|Nagaoka, Niigata, Japan, 940-2085|
|Contact: Kyuzi Kamoi, MD -81-0256-28-3600 email@example.com|
|Principal Investigator:||Kyuzi Kamoi, MD||Nagaoka Red Cross Hospital|