- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01681550
A Cohort Study of Incretin-based Therapy Combined With Insulin in Type 2 Diabetic Patients for 5 Years
Effect of Incretin-based Therapy Combined With Insulin on HbA1c, Hypoglycemia and Chronic Diabetic Complications in Type 2 Diabetic Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kyuzi Kamoi, MD
- Phone Number: +81-0258-28-3600
- Email: kkam-int@echigo.ne.jp
Study Locations
-
-
Niigata
-
Nagaoka, Niigata, Japan, 940-2085
- Nagaoka Red Cross Hospital
-
Contact:
- Kyuzi Kamoi, MD
- Phone Number: -81-0256-28-3600
- Email: kkam-int@echigo.ne.jp
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
After a detailed baseline examination, 500 Japanese subjects with type 2 diabetes were followed up for all-cause mortality and morbidity. All participants visited our clinic regularly. All patients were fully informed about the purposes and procedures for the study and provided oral consent at enrolment.
Exclusion Criteria:
Patients participating in other clinical study. Other than the above, patients judged inappropriate as the subjects of this study by the investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Incretin theapy combined with insulin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Duration varied between individual patients and was as the period of time after treatment with incretin-based therapy combined with insulin.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Average time requires 5 years
|
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.
|
Average time requires 5 years
|
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.
|
Average time requires 5 years
|
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.
|
Average time requires 5 years
|
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.
|
Average time requires 5 yearsinsulin.
|
Hypoglycemia
Time Frame: Average time requires 5 years
|
Hypoglycemia and the number of time per day were assessed by medical examination owing to interview.
|
Average time requires 5 years
|
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.
|
Average time requires 5 years
|
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.
|
Average time requires 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kyuzi Kamoi, MD, Nagaoka Red Cross Hospital
Publications and helpful links
General Publications
- 1. Rizos EC, Ntzani EE, Papanas N, Tsimihodimos V, Mitrogianni Z, Maltezos E, Elisaf MS. Combination therapies of DPP4 Inhibitors and GLP1 analogues with insulin in type 2 diabetic patients: A systematic review. Curr Vasc Pharmacol. 2012 Jun 22. [Epub ahead of print] 2. Jendle J, Martin SA, Milicevic Z. Insulin and GLP-1 analog combinations in type 2 diabetes mellitus: a critical review. Expert Opin Investig Drugs. 2012 Jul 16. [Epub ahead of print] 3. Lind M, Jendle J, Torffvit O, Lager I. Glucagon-like peptide 1 (GLP-1) analogue combined with insulin reduces HbA1c and weight with low risk of hypoglycemia and high treatment satisfaction. Prim Care Diabetes. 2012; 6: 41-46. 4. Kamoi K, Miyakoshi M, Soda S, Kaneko S, Nakagawa O. Usefulness of home blood pressure measurement in the morning in type 2 diabetic patients. Diabetes Care 2002; 25: 2218-2223.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8-Kamoi
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.
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