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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. Read our disclaimer for details. Identifier: NCT01681550
Recruitment Status : Unknown
Verified September 2012 by Kyuzi Kamoi, Nagaoka Red Cross Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 10, 2012
Last Update Posted : September 11, 2012
Information provided by (Responsible Party):
Kyuzi Kamoi, Nagaoka Red Cross Hospital

Brief Summary:

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

Detailed Description:
Patients were treated with diet, exercise, and/or oral conventional pharmacotherapy combined with insulin. Oral conventional pharmacotherapy consisted of α-glycosidase inhibitors (α-GI), sulfonylurea (SU), biguanide (BG), thiazolidinedione (TZD), or combinations of these agents. Insulin therapy consisted of subcutaneous injections of long-acting insulin analogues prior to sleep and bolus subcutaneous injections of rapid-acting insulin analogues in multiple daily injections, or subcutaneous injections of mixed insulin analogues twice a day. In spite of the treatments, when the physician in charge judged that their values of HbA1c were inappropriate, the physician added the pharmacotherapy combined the insulin to incretin-based therapy. 2.3.2. For ethical reasons, patients were treated with various anti-hypertensive, anti-diabetic, anti-dyslipidemia and/or anti-hypercoagulation agents during the course of the study by the patients' own doctors as a part of continuing standard medical care. As to the drugs that have been used for the treatment of other disorders and its complication since the time before the study, the content should not be changed during the study in principle unless the complication is cured. If any new complication occurs during the study period, an appropriate treatment is given by the judgment of investigator.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
Incretin theapy combined with insulin Drug: Incretin-based therapy

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Hypoglycemia [ Time Frame: Average time requires 5 years ]
    Hypoglycemia and the number of time per day were assessed by medical examination owing to interview.

  7. 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.

  8. 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.

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Ages Eligible for Study:   20 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01681550

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Contact: Kyuzi Kamoi, MD +81-0258-28-3600

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Nagaoka Red Cross Hospital Not yet recruiting
Nagaoka, Niigata, Japan, 940-2085
Contact: Kyuzi Kamoi, MD    -81-0256-28-3600   
Sponsors and Collaborators
Nagaoka Red Cross Hospital
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Principal Investigator: Kyuzi Kamoi, MD Nagaoka Red Cross Hospital

Publications of Results:
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.

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Responsible Party: Kyuzi Kamoi, MD, Nagaoka Red Cross Hospital Identifier: NCT01681550     History of Changes
Other Study ID Numbers: 8-Kamoi
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists