Effect of linagliptin on daily glucose excursion in continuous glucose monitoring of Japanese type 2 diabetic patients
| ISRCTN | ISRCTN16895010 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16895010 |
| Secondary identifying numbers | UMIN000010880 |
- Submission date
- 18/03/2017
- Registration date
- 23/03/2017
- Last edited
- 18/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
2-1-1 Hong Bunkyo-ku
Tokyo
113-8421
Japan
 ORCID ID |
0000-0002-0353-5807 |
|---|---|
| Phone | +81 3 5802 1579 |
| hk-sato@juntendo.ac.jp |
Study information
| Study design | Multi-center randomised open-label two-arm parallel comparative trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| 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 |
| Study acronym | L-CGM |
| Study objectives | Linagliptin is superior to voglibose in reducing glucose excursions in patients with type 2 diabetes. |
| Ethics approval(s) | The Fukushima Medical University Institutional Review Board, 27/05/2013, ref: No. 1682 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | Linagliptin |
| Primary outcome measure | 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 study start date | 01/02/2013 |
| Completion date | 01/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2013 |
| Date of final enrolment | 24/10/2013 |
Locations
Countries of recruitment
- Japan
Study participating centres
Fukushima
960-1295
Japan
Fukushima
960-8071
Japan
Iwaki
973-8402
Japan
Shibuya-ku Tokyo
Tokyo
150-8935
Japan
Hyogo
660-8511
Japan
Fukushima
960-0418
Japan
Chiba
273-8501
Japan
Tokyo
116-0012
Japan
Fukushima
960-8041
Japan
Iruma-gun
Saitama
350-0495
Japan
Fukushima
963-8851
Japan
Fukushima
961-0005
Japan
Fukushima
976-0016
Japan
Fukushima
973-8402
Japan
Tokyo
183-8524
Japan
Sponsor information
Research organisation
NBF Ogawamachi Building 4F 1-3-1
Ogawamachi
Kanda
Chiyoda-ku
Tokyo
101-0052
Japan
Funders
Funder type
Industry
No information available
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Lilly, Eli Lilly & Company, Eli Lilly & Co., Eli Lilly And Co
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/03/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/2017 | 18/02/2022 | Yes | No |
Editorial Notes
18/02/2022: Publication reference added.
