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Type 2 Diabetes MellitusNCT01681550

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

A study testing Incretin-based therapy in people with Type 2 Diabetes Mellitus, run by Nagaoka Red Cross Hospital at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 95 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Incretin-based therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteJapan
Study dates
Oct 2012to Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Kyuzi Kamoi, MD contact

+81-0258-28-3600

kkam-int@echigo.ne.jp

Japan1 site

  • Nagaoka Red Cross Hospital

    Nagaoka, Niigata, 940-2085

    Kyuzi Kamoi, MD, -81-0256-28-3600, kkam-int@echigo.ne.jp

Other trials in Japan

About this study

Official title: 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.

Read the 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.

Being tested
Incretin-based therapy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Incretin-based therapyDrug

Study groups in NCT01681550
Study groupRoleWhat they receive
Incretin theapy combined with insulinOtherNot described
Receives: Drug: Incretin-based therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death

    The cause of death was determined by attending doctor or was assessed by interviewing the family.

    Measured: Duration varied between individual patients and was as the period of time after treatment with incretin-based therapy combined with insulin.

Secondary outcomes (8)

  1. HbA1c

    Duration varied between individual patients and was as the period of time until after treatment with incretin-based therapy combined with insulin.

    Measured: Average time requires 5 years

  2. BMI

    BMI was calculated from body weight and height for at baseline and every 3 to 6 months throughout the study.

    Measured: Average time requires 5 years

  3. Blood pressure

    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.

    Measured: Average time requires 5 years

  4. Insulin dose

    Patients were treated with insulin analogues using MDI, or twice-daily injections. The dose was estimated by medical records.

    Measured: Average time requires 5 years

  5. Hypoglycemia

    Patients were treated with insulin analogues using MDI, or twice-daily injections. The dose was estimated by medical records.

    Measured: Average time requires 5 yearsinsulin.

  6. Hypoglycemia

    Hypoglycemia and the number of time per day were assessed by medical examination owing to interview.

    Measured: Average time requires 5 years

  7. Microvascular complications including renal anemia

    They were assessment by the method mentioned above. As renal anemia, serum hemoglobin (Hb) was measured by cyanmet-hemoglobin method using commercial reagent.

    Measured: Average time requires 5 years

  8. Macrovasular complications

    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.

    Measured: Average time requires 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionOct 2018 (estimated)
  4. Study completionOct 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01681550
Sponsor's protocol ID
8-Kamoi
Status last verified
Sep 2012
First submitted
2 Sep 2012
Last updated
11 Sep 2012
Results posted
No
Data monitoring committee
Yes

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.

Questions about this trial

What is this clinical trial studying?

A study testing Incretin-based therapy in people with Type 2 Diabetes Mellitus, run by Nagaoka Red Cross Hospital at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kyuzi Kamoi, MD (+81-0258-28-3600, kkam-int@echigo.ne.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death (time frame: Duration varied between individual patients and was as the period of time after treatment with incretin-based therapy combined with insulin.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01681550, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2012.

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