A Cohort Study of Incretin-based Therapy Combined With Insulin in Type 2 Diabetic Patients for 5 Years

NCT01681550 | Unknown DMC

• 1 other identifier: 8-Kamoi
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Death

  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 Outcomes (8)

• HbA1c

  Average time requires 5 years

• BMI

  Average time requires 5 years

• Blood pressure

  Average time requires 5 years

• Insulin dose

  Average time requires 5 years

• Hypoglycemia

  Average time requires 5 yearsinsulin.

Study Arms (1)

Incretin theapy combined with insulin

OTHER

Drug: Incretin-based therapy

Interventions

Incretin-based therapy DRUG

Incretin theapy combined with insulin

Eligibility Criteria

• Age: 20 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients participating in other clinical study. Other than the above, patients judged inappropriate as the subjects of this study by the investigator.

Sponsors & Collaborators

• Nagaoka Red Cross Hospital: lead

Study Sites (1)

Nagaoka Red Cross Hospital

Nagaoka, Niigata, 940-2085, Japan

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kyuzi Kamoi, MD

  Nagaoka Red Cross Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyuzi Kamoi, MD

CONTACT

+81-0258-28-3600; kkam-int@echigo.ne.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 2, 2012
• First Posted: September 10, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: September 11, 2012

Record last verified: 2012-09

Locations

JP (1)