Type 2 Diabetes MellitusPhase 1NCT01422590
Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin
A Phase 1 study testing Sitagliptin, Mitiglinide and Sitagliptin, Mitiglinide in people with Type 2 Diabetes Mellitus, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
1. Explore pharmacodynamics glucose insulin C-peptide glucagon intact GLP-1 DPP-4 activity CGMS (continuous glucose monitoring system) 2. Assess Safety adverse events clinical laboratory test physical examination Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Sitagliptin, Mitiglinide and Sitagliptin, Mitiglinide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Apr 2011
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients with type 2 diabetes mellitus
- 6.5% ≤ HbA1c < 9.0%
- Stopped treatment of sulfonylurea and biguanide for more than 8 weeks
- Stopped treatment of other anti-diabetic agents for more than 12 weeks
- 16 kg/m2 ≤ body mass index < 30 kg/m2
Who cannot join
- Fasting glucose ≥ 200 mg/dL
- Required insulin therapy
- Patients with neuropathy, retinopathy or renopathy
- Contraindicated for mitiglinide or sitagliptin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacodynamics After Concomitant Administration With Mitiglinide and Sitagliptin Compared to Mitiglinide, Sitagliptin Single Administration in Patients With Type 2 Diabetes
- Explore pharmacodynamics
- glucose
- insulin
- C-peptide
- glucagon
- intact GLP-1
- DPP-4 activity
- CGMS (continuous glucose monitoring system)
- Assess Safety
- adverse events
- clinical laboratory test
- physical examination
Read the detailed description
Pharmacodynamic assessment
- CGMS data is obtained from day 1 to day 3 (48 hours)
- PD is measured before (day 1) and after drug administration (day 2)
- AUC of glucose, insulin, C-peptide, glucagon, intact GLP-1, DPP-4 activity
- MAGE (mean amplitude of glycemic excursion) from CGMS data
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Sitagliptin, Mitiglinide, Sitagliptin, Mitiglinide
- Keywords
- sitagliptin, mitiglinide, type 2 diabetes mellitus, Pharmacodynamics, Safety
- 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.
SitagliptinDrug
Single oral administration of sitagliptin 100 mg
MitiglinideDrug
Single oral administration of mitiglinide 10 mg
Sitagliptin, MitiglinideDrug
Concomitant administration of sitagliptin 100 mg and mitiglinide 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Active comparator | Not described Receives: Drug: Sitagliptin |
| Mitiglinide | Active comparator | Not described Receives: Drug: Mitiglinide |
| Sitagliptin + Mitiglinide | Experimental | Not described Receives: Drug: Sitagliptin, Mitiglinide |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (area under the curve) of plasma glucose
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
Measured: day 1 and day 2 of each period
AUC of insulin
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
Measured: day 1 and day 2 of each period
AUC of intact GLP-1
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
Measured: day 1 and day 2 of each period
AUC of C-peptide
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
Measured: day 1 and day 2 of each period
AUC of glucagon
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
Measured: day 1 and day 2 of each period
MAGE
Differences of MAGE before treatment (day 1) and after treatment (day 2) is compared between treatment groups
Measured: day 1 and day 2 of each period
AUC of DPP-4 activity
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
Measured: day 1 and day 2 of each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startMay 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- JW Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Wooseong Hur, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422590
- Sponsor's protocol ID
- 2010-04-071
- Status last verified
- Sep 2011
- First submitted
- 10 Aug 2011
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Jung JA, Kaku K, Kim JH, Kim JR, Ko JW, Lee SY, Huh W. Additive postprandial glucose-lowering effects of mitiglinide and sitagliptin in patients with type 2 diabetes mellitus. Adv Ther. 2013 Nov;30(11):1018-29. doi: 10.1007/s12325-013-0072-x. Epub 2013 Nov 19.
PubMed 24249434
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamics After Concomitant Administration With Mitiglinide and Sitagliptin Compared to Mitiglinide, Sitagliptin Single Administration in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01422590
- Acronym / sponsor ID
- 2010-04-071
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- sitagliptin, mitiglinide, type 2 diabetes mellitus, Pharmacodynamics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- JW Pharmaceutical
- Study start
- May 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 24 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Explore pharmacodynamics
- glucose
- insulin
- C-peptide
- glucagon
- intact GLP-1
- DPP-4 activity
- CGMS (continuous glucose monitoring system)
- Assess Safety
- adverse events
- clinical laboratory test
- physical examination
Detailed description
Pharmacodynamic assessment
- CGMS data is obtained from day 1 to day 3 (48 hours)
- PD is measured before (day 1) and after drug administration (day 2)
- AUC of glucose, insulin, C-peptide, glucagon, intact GLP-1, DPP-4 activity
- MAGE (mean amplitude of glycemic excursion) from CGMS data
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Active comparator | Drug: Sitagliptin |
| Mitiglinide | Active comparator | Drug: Mitiglinide |
| Sitagliptin + Mitiglinide | Experimental | Drug: Sitagliptin, Mitiglinide |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients with type 2 diabetes mellitus
- 6.5% ≤ HbA1c < 9.0%
- Stopped treatment of sulfonylurea and biguanide for more than 8 weeks
- Stopped treatment of other anti-diabetic agents for more than 12 weeks
- 16 kg/m2 ≤ body mass index < 30 kg/m2
Key exclusion criteria (4 listed)
- Fasting glucose ≥ 200 mg/dL
- Required insulin therapy
- Patients with neuropathy, retinopathy or renopathy
- Contraindicated for mitiglinide or sitagliptin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SitagliptinSingle oral administration of sitagliptin 100 mg | Drug | Sitagliptin |
| MitiglinideSingle oral administration of mitiglinide 10 mg | Drug | Mitiglinide |
| Sitagliptin, MitiglinideConcomitant administration of sitagliptin 100 mg and mitiglinide 10 mg | Drug | Sitagliptin + Mitiglinide |
Primary outcome
AUC (area under the curve) of plasma glucose
Time frame: day 1 and day 2 of each period
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
AUC of insulin
Time frame: day 1 and day 2 of each period
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
AUC of intact GLP-1
Time frame: day 1 and day 2 of each period
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
AUC of C-peptide
Time frame: day 1 and day 2 of each period
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
AUC of glucagon
Time frame: day 1 and day 2 of each period
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
MAGE
Time frame: day 1 and day 2 of each period
Differences of MAGE before treatment (day 1) and after treatment (day 2) is compared between treatment groups
AUC of DPP-4 activity
Time frame: day 1 and day 2 of each period
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
- Derived from this study: PubMed 24249434Jung JA, Kaku K, Kim JH, Kim JR, Ko JW, Lee SY, Huh W. Additive postprandial glucose-lowering effects of mitiglinide and sitagliptin in patients with type 2 diabetes mellitus. Adv Ther. 2013 Nov;30(11):1018-29. doi: 10.1007/s12325-013-0072-x. Epub 2013 Nov 19.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wooseong Hur, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sitagliptin, Mitiglinide and Sitagliptin, Mitiglinide in people with Type 2 Diabetes Mellitus, run by Samsung Medical Center at 1 site in South Korea.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 7 Sep 2011. 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 South Korea. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (area under the curve) of plasma glucose (time frame: day 1 and day 2 of each period). The study lists 7 primary outcomes in all. 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 NCT01422590, 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 7 Sep 2011.