Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/08/2007
Date assigned
17/08/2007
Last edited
17/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Takashi Okamoto

ORCID ID

Contact details

793-1
Second ward
Tanno
Kitami
Hokkaido
099-2102
Japan
+81 157 67 6000
t.okamoto@okhotsk-kai.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Insulin injection treatment is associated with pain and puts a heavy physical, mental, and financial burden on patients. In this study, we aim to develop a novel method to change the route of administration of hypoglycemic agents from needle-mediated to oral, thereby enabling patients with type 2 diabetes to have a more comfortable life by being liberated from painful procedures and recurrent insulin-induced hypoglycemic incidents. Pioglitazone is a newly available agent that improves insulin resistance, a core defect in type 2 diabetes. Since pioglitazone has not been used as a major agent for switching, this study uses this agent together with a sulphonylurea, glimepiride and an alpha glucosidase inhibitor, voglibose to develop a new approach for the substitution of insulin therapy. Since insulin injection per se may exacerbate insulin resistance, we completely stop insulin injections before the switch and then immediately administer oral agents in patients under long-term insulin injection in order to maximize pioglitazone's insulin-sensitizing capacity.

Ethics approval

Kitami Medical Association Institutional Review Board, approved on 03/07/2006 (ref: 06-B-108)

Study design

Non-randomised controlled trial (all participants received the same interventions and there was no control group).

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Type 2 diabetes

Intervention

All participants are hospitalized. On the day insulin injection therapy is completely withdrawn, the therapy with oral hypoglycemic agents (combination therapy) is initiated.

The initial doses are: 15-30 mg Pioglitazone ,1-3 mg glimepiride, and 0.9 mg voglibose. The maximum dose of pioglitazone is 45 mg, and that of glimepiride is 4 mg. If fasting plasma glucose is less than 5.55 mmol/l and/or hypoglycemia developed, glimepiride is first reduced in dosage and then pioglitazone.

Duration of interventions: 4 months.

Intervention type

Drug

Phase

Not Specified

Drug names

pioglitazone, glimepiride and voglibose

Primary outcome measures

Rate of success in the study. Success is defined as HbA1c at four months after the switch <7.0%.

Secondary outcome measures

Difference in mean HbA1C from the baseline compared to four-month timepoint. Differences among values of the following are also assessed (measured at months 0 and 4):

1. Serum lipid concentrations
2. Blood pressure
3. Body weight
4. Hematocrit
5. Albumin
6. Blood urea nitrogen
7. Creatinine
8. Aspartate Transaminase (AST)
9. Alanine Transaminase (ALT)

Overall trial start date

01/05/2005

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with type 2 diabetes under long-term insulin injection
2. Age between 40 and 86 years
3. Insulin dosage >10 units/24 h
4. Insulin injection duration >3 months
5. C-peptide in 24-hr urine >10 micrograms
6. Fasting CPR >0.5 ng/ml

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Positive for glutamine acid decarboxylase antibody
2. ALT and/or AST >3 times the upper limit of normal
3. Presently and/or in the past suffering from heart failure
4. Ejection fraction assessed by echocardiography <40%
5. Malignancy on active therapeutic regimen or without complete remission or cure
6. Concomitantly suffering from infection
7. Planning to have surgery
8. >50% positivity for insulin antibody
9. Diagnosis of type I diabetes
10. Pregnant or breast feeding
11. Under dialysis
12. Concomitantly using pioglitazone

Recruitment start date

01/05/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Japan

Trial participating centre

793-1
Hokkaido
099-2102
Japan

Sponsor information

Organisation

Okhotsk-kai Hospital (Japan)

Sponsor details

793-1
Second ward
Tanno
Kitami
Hokkaido
099-2102
Japan
+81 157676000
t.okamoto@okhotsk-kai.com

Sponsor type

Hospital/treatment centre

Website

http://www.okhotsk-kai.com/

Funders

Funder type

Hospital/treatment centre

Funder name

Okhotsk-kai Hospital (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes