Switch to oral hypoglycemic agent therapy from insulin injection in patients with type 2 diabetes

ISRCTN	ISRCTN35210312
DOI	https://doi.org/10.1186/ISRCTN35210312
Secondary identifying numbers	N/A

Submission date: 10/08/2007
Registration date: 17/08/2007
Last edited: 29/10/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Takashi Okamoto
Scientific

793-1
Second ward
Tanno
Kitami
Hokkaido
099-2102
Japan

Phone	+81 157 67 6000
Email	t.okamoto@okhotsk-kai.com

Study information

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
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Switch to oral hypoglycemic agent therapy from insulin injection in patients with type 2 diabetes
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(s)	Kitami Medical Association Institutional Review Board, approved on 03/07/2006 (ref: 06-B-108)
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 On the day insulin injection therapy is completely withdrawn, the therapy with oral hypoglycemic agents (combination therapy) is initiated.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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	pioglitazone, glimepiride and voglibose
Primary outcome measure	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 study start date	01/05/2005
Overall study end date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	40
Total final enrolment	36
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 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

Study participating centre

793-1

Hokkaido
099-2102
Japan

Sponsor information

Okhotsk-kai Hospital (Japan)
Hospital/treatment centre

793-1
Second ward
Tanno
Kitami
Hokkaido
099-2102
Japan

Phone	+81 157676000
Email	t.okamoto@okhotsk-kai.com
Website	http://www.okhotsk-kai.com/
"ROR"	https://ror.org/0261c1d14

Funders

Funder type

Hospital/treatment centre

Okhotsk-kai Hospital (Japan)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		11/11/2008	29/10/2021	Yes	No

Editorial Notes

29/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.