Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/03/2017
Date assigned
23/03/2017
Last edited
23/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Diabetes is a life-long condition where a person is unable to control their blood sugar levels. Type 2 diabetes is a type of diabetes that usually occurs later in life and happens when the pancreas does not produce enough insulin (a hormone) or the body does not react to insulin as it is supposed to. It can be caused by certain risk factors such as weight, age, and genetics. Controlling glucose (sugar levels) is very important to prevent complications as fluctuating glucose levels induce stress and this may increase the risk of heart complications. Previous research has shown that daily glucose levels should be controlled especially in order to prevent heart issues. There are certain medications that can assist in controlling glucose such as linagliptin (increases the amount of insulin that the body produces) or voglibose (lowers blood sugar levels by delaying the absorption of glucose in the blood). Using continuous glucose monitoring, people are now able to check their blood sugar levels in real time, which helps measure their glucose levels. GCM is a small device that is worn under the skin that senses blood glucose levels, allowing the wearer to track their levels throughout the day. This can help people control their daily changes which may minimize heart issues in patients with diabetes in the future. This study aims to compare the effects of linagliptin and voglibose on daily glucose excursion in Japanese patients with type 2 diabetes using continuous glucose monitoring (CGM).

Who can participate?
Adults aged 20 or older who have diabetes.

What does the study involve?
Participants undergo two CGM evaluations at the beginning of the treatment and at the end of the treatment. They receive three standardized meals (breakfast, lunch and dinner) on the third day of their CGM evaluation. After this, participants are randomly allocated to one of two groups. Those in the first group take linagliptin (5 milligrams per day) by mouth. Those in the second group take voglibose (0.6 milligram per day) by mouth three times daily (with their meals) for 12 weeks. Participants are evaluated at the end of the treatment to see if there are any changes in their glucose levels.

What are the possible benefits and risks of participating?
Participants may benefit from obtaining their daily glucose levels by using the CGM. There are no notable risks with participating.

Where is the study run from?
This study is being run from Fukushima Medical University (Japan) and takes place in 14 hospitals/clinics in Japan.

When is the study starting and how long is it expected to run for?
February 2013 to March 2017.

Who is funding the study?
Nippon Boehringer Ingelheim Co. Ltd. (Japan)

Who is the main contact?
Dr Hiroaki Satoh
hk-sato@juntendo.ac.jp

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hiroaki Satoh

ORCID ID

http://orcid.org/0000-0002-0353-5807

Contact details

2-1-1 Hong Bunkyo-ku
Tokyo
113-8421
Japan
+81 3 5802 1579
hk-sato@juntendo.ac.jp

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UMIN000010880

Study information

Scientific title

Linagliptin versus voglibose on glucose excursion in japanese patients with type 2 diabetes mellitus: effect of linagliptin on daily glucose excursion in continuous glucose monitoring of Japanese type 2 diabetic patients (L-CGM study): a 12-week randomized, open-label, 2-arm parallel comparative trial

Acronym

L-CGM

Study hypothesis

Linagliptin is superior to voglibose in reducing glucose excursions in patients with type 2 diabetes.

Ethics approval

The Fukushima Medical University Institutional Review Board, 27/05/2013, ref: No. 1682

Study design

Multi-center randomised open-label two-arm parallel comparative trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Type 2 diabetes

Intervention

Participants are randomly allocated to one of two groups using a dynamic allocation method based on baseline measurements of HbA1c and BMI. Participants undergo Continuous Glucose Monitorin (CGM) evaluation using an iPro2 device (Medtronic Minimed, Northridge, CA, USA) for two three-day periods at baseline and 12 weeks. Data is collected in blinded fashion and analysed centrally. During the third day of CGM periods, three standardised meals (breakfast, lunch and dinner) are delivered to each subject. Patients unable to consume a standardised meal for lunch (i.e. due to work restrictions, travel or unexpected events) consumed a calorie-restricted meal (1,800 kcal/day, 60% carbohydrates, 25% fat and 15% protein) equivalent to a standardised meal.

Participants then take the medication according to the group they are allocated to. Those in group one take linagliptin (5 mg/day) orally according to the treatments group assignment for 12 weeks. Those in group two take vogibose (0.2 mg/meal) orally three times a day with each meal according to treatments group assignment for 12 weeks.

Participants are followed up at the end of the 12 weeks to evaluate changes in mean 24-hour glucose levels, mean amplitude of glycemic excursion (MAGE), and standard deviation of the mean 24-hour CGM blood glucose reading.

Intervention type

Drug

Phase

Drug names

Linagliptin

Primary outcome measures

1. Mean 24 hour glucose level is measured using blood samples at baseline and 12 weeks
2. Mean amplitude of glycemic excursion (MAGE) is measured using blood samples at baseline and 12 weeks
3. Standard deviation of mean 24-hour CGM blood glucose readings are measured using blood samples at baseline and 12 weeks

Secondary outcome measures

1. HbA1c is measured using blood samples at baseline and 12 weeks
2. Levels of glycoalbumin (GA) are measured using blood samples at baseline and 12 weeks
3. 1,5-anhydroglucitol (1,5-AG) are measured using bloo samples at baseline and 12 weeks
4. Homeostatic model assessment (HOMA)-IR measured using blood samples at baseline and 12 weeks
5. HOMA-β is measured using blood samples at baseline and 12 weeks
6. Insulin is measured using blood samples at baseline and 12 weeks
7. C-peptide is measured using blood samples at baseline and 12 weeks
8. Glucagon is measured using blood samples at baseline and 12 weeks
9. Adiponectin is measured using blood samples at baseline and 12 weeks
10. Resistin is measured using blood samples at baseline and 12 weeks
11. tumor necrosis factor (TNF)-α is measured using blood samples at baseline and 12 weeks
12. Lipid parameters (including triglycerides (TG), total cholesterol (TC), high-density lipoprotein (HDL)-C, low-density lipoprotein (LDL)-C, and free fatty acids (FFA)) are measured using blood samples at baseline and 12 weeks
13. Regimen safety is measured using blood samples at baseline and 12 weeks

Overall trial start date

01/02/2013

Overall trial end date

01/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Type 2 diabetes
2. No treatment with any anti-diabetes drugs within 12 weeks
3. HbA1c of 6.5%–10.0%
4. Body mass index (BMI) of 18.5–34.9 kg/m2
5. Estimated glomerular filtration rate (eGFR) ≥45 mL/min/m2
6. Aged 20 years or older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Type 1 or secondary diabetes
2. Presence of severe preoperative- or postoperative infectious disease or severe trauma
3. History of myocardial infarction, angina pectoris, cerebral stroke, or cerebral infarction within the previous 3 months;
4. Moderate or severe heart failure (New York Heart Association stage III or higher)
5. Severe liver dysfunction (aspartate aminotransferase (AST), aspartate transaminase (ALT) or alkaline phosphatase (ALP) exceeding three times the upper limit of normal)
6. History of allergy or hypersensitivity to any drug
7. Alcohol abuse or drug dependence
8. Pregnancy or possible pregnancy, lactation, or intent to become pregnant during the study period;
9. History of cancer, open abdominal surgery, or ileus
10. Oral or intravenous corticosteroid therapy
11. Determination of ineligibility by clinical investigators

Recruitment start date

01/07/2013

Recruitment end date

24/10/2013

Locations

Countries of recruitment

Japan

Trial participating centre

Fukushima Medical University
1 Hikarigaoka Fukushima-City
Fukushima
960-1295
Japan

Trial participating centre

Fukushima Seibu Hospital
3-15 Higashichuo Fukushima-City
Fukushima
960-8071
Japan

Trial participating centre

Iwaki Kyoritsu General Hospital
16 Kusehara Uchigomimayamachi Iwaki-City
Iwaki
973-8402
Japan

Trial participating centre

Japanese Red Cross Medical Center
4-1-22 Hiroo Shibuya-ku Tokyo
Tokyo
150-8935
Japan

Trial participating centre

Kansai Rosai Hospital
3-1-69 Inabsou Amagasaki-City
Hyogo
660-8511
Japan

Trial participating centre

Kashinoki Naika Clinic
20-6 Okamae Date-City
Fukushima
960-0418
Japan

Trial participating centre

Misaki Naika Clinic
6-44-9 Miwahigashi Funabashi-City
Chiba
273-8501
Japan

Trial participating centre

Nishimura Clinic
8-14-1 Higashioku Arakawa-ku
Tokyo
116-0012
Japan

Trial participating centre

Ohara General Hospital
6-1-1 Omachi Fukushima-City
Fukushima
960-8041
Japan

Trial participating centre

Saitama Medical University Hospital
38 Morohongo Moroyama-Machi Iruma-gun
Saitama
350-0495
Japan

Trial participating centre

Seino Internal Medicine Clinic
6-192-2 Kaisei Koriyama-City
Fukushima
963-8851
Japan

Trial participating centre

Shirakawa Kosei Hospital
2-1 Toyochikamiyajiro Shirakawa-City
Fukushima
961-0005
Japan

Trial participating centre

Soma Central Hospital
3-5-18 Okinouchi Soma-City
Fukushima
976-0016
Japan

Trial participating centre

Taneda Clinic
3-82-2 Uchigomimayamachi Iwaki-City
Fukushima
973-8402
Japan

Trial participating centre

Tokyo Metropolitan Tama Medical Center
2-8-29 Musashidai Fuchu-City
Tokyo
183-8524
Japan

Sponsor information

Organisation

Japan Society for Patient Reported Outcome

Sponsor details

NBF Ogawamachi Building 4F 1-3-1
Ogawamachi
Kanda
Chiyoda-ku
Tokyo
101-0052
Japan

Sponsor type

Research organisation

Website

Funders

Funder type

Industry

Funder name

Nippon Boehringer Ingelheim Co. Ltd.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Eli Lilly and Company

Alternative name(s)

Lilly

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Planned publication to peer-reviewed high impact journal.

IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Hiroaki Satoh hk-sato@juntendo.ac.jp

Intention to publish date

31/03/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes