Type 2 Diabetes MellitusPhase 1NCT01582308

A Study Comparing the Pharmacokinetic and Pharmacodynamic Profiles for Sitagliptin, Saxagliptin and Vildagliptin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-142)

A Phase 1 study testing Sitagliptin 100 mg, Saxagliptin 5 mg and Vildagliptin 50 mg in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Sitagliptin 100 mg, Saxagliptin 5 mg and Vildagliptin 50 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: No sites listed yet
Study dates: 21 Jun 2012to 14 Dec 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

female participants of reproductive potential must not be pregnant and agree to use (and/or have their partner use) two acceptable methods of birth control beginning at least 2 weeks prior to administration of the first dose of study drug until at least 2 weeks after the last administration of study drug
has a body mass index between 18 and 43 kg/m^2 inclusive
has a clinically confirmed diagnosis of T2DM
is not currently receiving any oral antihyperglycemic medications and has a screening visit hemoglobin A1c (HbA1c) between 6.5% and 10% inclusive
must not have been previously treated with a DPP-4 inhibitor or glucagon-like peptide-1 analogs within 12 weeks of prestudy visit
has fasting plasma or serum glucose (FPG) ≤200 mg/dL (11.1 mmol/L) at screening and randomization

Show all 10Show fewer

is a non-smoker or has not used nicotine or nicotine-containing products for at least approximately the last 6 months
is willing to follow the American Heart Association weight maintaining diet and exercise program or equivalent beginning 2 weeks prior to administration of first dose of study drug and throughout the study until the poststudy visit
agrees to refrain from the consumption of grapefruit and grapefruit juice for at least 2 weeks prior to the start of the study and throughout the study
agrees to refrain from the consumption of all fruit juices periodically throughout the study

Who cannot join

is mentally or legally incapacitated, has significant emotional problems at the time of prestudy visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 5 years
has an estimated creatinine clearance of ≤60 mL/min
has a history of stroke, chronic seizures, or major neurological disorder
has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases (with the exception of stable thyroid disease, T2DM and typical associated diseases such as hypertension and hyperlipidemia)
must not have been previously treated with any regimen that includes insulin (injected or inhaled) for at least 3 months
has a history of type 1 diabetes mellitus and/or history of ketoacidosis, or C peptide ≤0.8 ng/mL (≤0.26 nmol/L); or secondary forms of diabetes, acute metabolic diabetic complications or evidence of significant diabetic complications (i.e. retinopathy, neuropathy, nephropathy)

Show all 18Show fewer

has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease
is on a weight loss program and is not in the maintenance phase, or participant has been treated with a weight loss medication within 8 weeks of screening
anticipates the use of any new medication(s), including prescription and non-prescription drugs or herbal remedies beginning approximately 2 weeks prior to administration of the initial dose of study drug and throughout the study until the poststudy visit
anticipates any change in dose of current stable medications
has donated or lost 1 unit of blood within 4 weeks of the prestudy visit
has had major surgery within 30 days prior to screening or has planned major surgery
has a history of uncontrolled hypertension
is taking a medication which is not permitted in the study to treat a co-morbid condition, including but not limited to cytochrome P450 3A4/5 inhibitors and inducers, P-glycoprotein 1 inhibitors, and human organic anion transporter 3 inhibitors
consumes excessive amounts of alcohol, coffee, tea, cola, or other caffeinated beverage daily
has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
is currently a regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately the past 6 months
is a nursing mother

About this study

Official title: A Study to Assess and Compare the Pharmacokinetic and Pharmacodynamic Profiles for Sitagliptin, Saxagliptin and Vildagliptin in Patients With Type 2 Diabetes Mellitus

A five-period crossover study to assess and compare the trough dipeptidyl peptidase IV (DPP-4) inhibition at 24-hours following the final morning dose for sitagliptin, saxagliptin and vildagliptin after 5 days of once daily dosing and vildagliptin after 5 days of twice daily dosing in participants with T2DM. The primary hypothesis is that following multiple daily dose administration to achieve steady-state drug concentrations, 100-mg sitagliptin will demonstrate greater DPP-4 inhibition at 24-hours after the final dose compared to 5-mg saxagliptin and 50-mg vildagliptin (once daily administration) in participants with T2DM. Each participant will receive all 5 treatments in randomized order. There will be a washout interval of at least 10 days between the last dose of study drug in one period and the first dose of study drug in the following period.

Conditions: Type 2 Diabetes Mellitus
Being tested: Sitagliptin 100 mg, Saxagliptin 5 mg, Vildagliptin 50 mg, Vildagliptin 50 mg BID, Placebo
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.

Sitagliptin 100 mgDrug
Also called Januvia™
Sitagliptin 100 mg: one sitagliptin 100 mg tablet once daily in the morning following a fast of at least approximately 8 hours on Days 1 through 5 in one out of five treatment periods.
Saxagliptin 5 mgDrug
Also called Onglyza™
Saxagliptin 5 mg: one saxagliptin 5 mg tablet once daily in the morning following a fast of at least approximately 8 hours on Days 1 through 5 in one out of five treatment periods.
Vildagliptin 50 mgDrug
Also called Galvus™
Vildagliptin 50 mg: one vildagliptin 50 mg tablet once daily in the morning following a fast of at least approximately 8 hours on Days 1 through 5 in one out of five treatment periods.
Vildagliptin 50 mg BIDDrug
Also called Galvus™
Vildagliptin 50 mg BID: one vildagliptin 50 mg tablet BID (twice daily), once in the morning following a fast of at least approximately 8 hours and once in the evening on Days 1 through 5 in one out of five treatment periods.
PlaceboDrug
Placebo: one placebo for sitagliptin tablet once daily in the morning following a fast of at least approximately 8 hours on Days 1 through 5 in one out of five treatment periods.

Study groups in NCT01582308
Study group	Role	What they receive
Treatment Sequence 1	Experimental	Sitagliptin 100 mg in Period 1 followed by saxagliptin 5 mg in Period 2 followed by vildagliptin 50 mg BID in Period 3 followed by placebo in Period 4 followed by vildagliptin 50 mg in Period 5 Receives: Drug: Sitagliptin 100 mg; Drug: Saxagliptin 5 mg; Drug: Vildagliptin 50 mg; Drug: Vildagliptin 50 mg BID; Drug: Placebo
Treatment Sequence 2	Experimental	Saxagliptin 5 mg in Period 1 followed by vildagliptin 50 mg in Period 2 followed by placebo in Period 3 followed by sitagliptin 100 mg in Period 4 followed by vildagliptin 50 mg BID in Period 5 Receives: Drug: Sitagliptin 100 mg; Drug: Saxagliptin 5 mg; Drug: Vildagliptin 50 mg; Drug: Vildagliptin 50 mg BID; Drug: Placebo
Treatment Sequence 3	Experimental	Vildagliptin 50 mg in Period 1 followed by vildagliptin 50 mg BID in Period 2 followed by sitagliptin 100 mg in Period 3 followed by saxagliptin 5 mg in Period 4 followed by placebo in Period 5 Receives: Drug: Sitagliptin 100 mg; Drug: Saxagliptin 5 mg; Drug: Vildagliptin 50 mg; Drug: Vildagliptin 50 mg BID; Drug: Placebo
Treatment Sequence 4	Experimental	Vildagliptin 50 mg BID in Period 1 followed by placebo in Period 2 followed by saxagliptin 5 mg in Period 3 followed by vildagliptin 50 mg in Period 4 followed by sitagliptin 100 mg in Period 5 Receives: Drug: Sitagliptin 100 mg; Drug: Saxagliptin 5 mg; Drug: Vildagliptin 50 mg; Drug: Vildagliptin 50 mg BID; Drug: Placebo
Treatment Sequence 5	Experimental	Placebo in Period 1 followed by sitagliptin 100 mg in Period 2 followed by vildagliptin 50 mg in Period 3 followed by vildagliptin 50 mg BID in Period 4 followed by saxagliptin 5 mg in Period 5 Receives: Drug: Sitagliptin 100 mg; Drug: Saxagliptin 5 mg; Drug: Vildagliptin 50 mg; Drug: Vildagliptin 50 mg BID; Drug: Placebo
Treatment Sequence 6	Experimental	Sitagliptin 100 mg in Period 1 followed by vildagliptin 50 mg in Period 2 followed by saxagliptin 5 mg in Period 3 followed by placebo in Period 4 followed by vildagliptin 50 mg BID in Period 5 Receives: Drug: Sitagliptin 100 mg; Drug: Saxagliptin 5 mg; Drug: Vildagliptin 50 mg; Drug: Vildagliptin 50 mg BID; Drug: Placebo
Treatment Sequence 7	Experimental	Saxagliptin 5 mg in Period 1 followed by vildagliptin 50 mg BID in Period 2 followed by vildagliptin 50 mg in Period 3 followed by sitagliptin 100 mg in Period 4 followed by placebo in Period 5 Receives: Drug: Sitagliptin 100 mg; Drug: Saxagliptin 5 mg; Drug: Vildagliptin 50 mg; Drug: Vildagliptin 50 mg BID; Drug: Placebo
Treatment Sequence 8	Experimental	Vildagliptin 50 mg in Period 1 followed by placebo in Period 2 followed by vildagliptin 50 mg BID in Period 3 followed by saxagliptin 5 mg in Period 4 followed by sitagliptin 100 mg in Period 5 Receives: Drug: Sitagliptin 100 mg; Drug: Saxagliptin 5 mg; Drug: Vildagliptin 50 mg; Drug: Vildagliptin 50 mg BID; Drug: Placebo
Treatment Sequence 9	Experimental	Vildagliptin 50 mg BID in Period 1 followed by sitagliptin 100 mg in Period 2 followed by placebo in Period 3 followed by vildagliptin 50 mg in Period 4 followed by saxagliptin 5 mg in Period 5 Receives: Drug: Sitagliptin 100 mg; Drug: Saxagliptin 5 mg; Drug: Vildagliptin 50 mg; Drug: Vildagliptin 50 mg BID; Drug: Placebo
Treatment Sequence 10	Experimental	Placebo in Period 1 followed by saxagliptin 5 mg in Period 2 followed by sitagliptin 100 mg in Period 3 followed by vildagliptin 50 mg BID in Period 4 followed by vildagliptin 50 mg in Period 5 Receives: Drug: Sitagliptin 100 mg; Drug: Saxagliptin 5 mg; Drug: Vildagliptin 50 mg; Drug: Vildagliptin 50 mg BID; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Inhibition of Dipeptidyl Peptidase IV (DPP-4) Activity at Trough
Percent inhibition of DPP-4 activity at 24 hours after the Day 5 morning dose (i.e., at trough) was determined by analysis of blood samples collected from the study participants.
Measured: 24 hours following the final morning dose on Day 5

Secondary outcomes (4)

Pharmacokinetic Analysis: Area Under the Curve 0-24 Hours (AUC 0-24hr)
AUC 0-24hr is the area under the plasma drug concentration-time curve calculated for the 24 hour interval after the Day 5 morning dose.
Measured: Predose (0 Hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20 and 24 hours after the morning dose on Day 5
Pharmacokinetic Analysis: Area Under the Curve 0-12 Hours (AUC 0-12hr) for Vildagliptin 50 mg BID
AUC 0-12hr is the area under the plasma drug concentration-time curve calculated for the 12 hour interval after the Day 5 morning dose for the vildagliptin 50 mg BID dose only.
Measured: Predose (0 hours) and 0.5, 1, 2, 4, 8 and 12 hours after the morning dose on Day 5
Pharmacokinetic Analysis: Peak Plasma Drug Concentration (Cmax)
Measurement of the peak plasma drug concentration following the Day 5 morning dose.
Measured: Predose (0 hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20, 24, 36, 48 and 96 hours after the morning dose on Day 5
Pharmacokinetic Analysis: Time to the Peak Plasma Drug Concentration (Tmax)
Measurement of the time to the peak plasma drug concentration following the Day 5 morning dose.
Measured: Predose (0 hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20, 24, 36, 48 and 96 hours after the morning dose on Day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 201214 Dec 2012

First posted20 Apr 2012 (estimated)
Study start21 Jun 2012
Primary completion4 Dec 2012
Study completion14 Dec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 Merck Sharp & Dohme LLCThe 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: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01582308
Sponsor's protocol ID: 0431-142
Other IDs: 2011-005567-25
Status last verified: Apr 2017
First submitted: 19 Apr 2012
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Tatosian DA, Guo Y, Schaeffer AK, Gaibu N, Popa S, Stoch A, Langdon RB, Kauh EA. Dipeptidyl peptidase-4 inhibition in patients with type 2 diabetes treated with saxagliptin, sitagliptin, or vildagliptin. Diabetes Ther. 2013 Dec;4(2):431-42. doi: 10.1007/s13300-013-0045-8. Epub 2013 Oct 26.
PubMed 24163113

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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)

All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Assess and Compare the Pharmacokinetic and Pharmacodynamic Profiles for Sitagliptin, Saxagliptin and Vildagliptin in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01582308
Acronym / sponsor ID: 0431-142
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 21 Jun 2012 (actual)
Primary completion: 4 Dec 2012 (actual)
Study completion: 14 Dec 2012 (actual)
First posted: 20 Apr 2012 (estimated)
Results: Posted 22 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 10

Arm	Type	Receives
Treatment Sequence 1	Experimental	Drug: Sitagliptin 100 mg, Drug: Saxagliptin 5 mg, Drug: Vildagliptin 50 mg, Drug: Vildagliptin 50 mg BID, Drug: PlaceboSitagliptin 100 mg in Period 1 followed by saxagliptin 5 mg in Period 2 followed by vildagliptin 50 mg BID in Period 3 followed by placebo in Period 4 followed by vildagliptin 50 mg in Period 5
Treatment Sequence 2	Experimental	Drug: Sitagliptin 100 mg, Drug: Saxagliptin 5 mg, Drug: Vildagliptin 50 mg, Drug: Vildagliptin 50 mg BID, Drug: PlaceboSaxagliptin 5 mg in Period 1 followed by vildagliptin 50 mg in Period 2 followed by placebo in Period 3 followed by sitagliptin 100 mg in Period 4 followed by vildagliptin 50 mg BID in Period 5
Treatment Sequence 3	Experimental	Drug: Sitagliptin 100 mg, Drug: Saxagliptin 5 mg, Drug: Vildagliptin 50 mg, Drug: Vildagliptin 50 mg BID, Drug: PlaceboVildagliptin 50 mg in Period 1 followed by vildagliptin 50 mg BID in Period 2 followed by sitagliptin 100 mg in Period 3 followed by saxagliptin 5 mg in Period 4 followed by placebo in Period 5
Treatment Sequence 4	Experimental	Drug: Sitagliptin 100 mg, Drug: Saxagliptin 5 mg, Drug: Vildagliptin 50 mg, Drug: Vildagliptin 50 mg BID, Drug: PlaceboVildagliptin 50 mg BID in Period 1 followed by placebo in Period 2 followed by saxagliptin 5 mg in Period 3 followed by vildagliptin 50 mg in Period 4 followed by sitagliptin 100 mg in Period 5
Treatment Sequence 5	Experimental	Drug: Sitagliptin 100 mg, Drug: Saxagliptin 5 mg, Drug: Vildagliptin 50 mg, Drug: Vildagliptin 50 mg BID, Drug: PlaceboPlacebo in Period 1 followed by sitagliptin 100 mg in Period 2 followed by vildagliptin 50 mg in Period 3 followed by vildagliptin 50 mg BID in Period 4 followed by saxagliptin 5 mg in Period 5
Treatment Sequence 6	Experimental	Drug: Sitagliptin 100 mg, Drug: Saxagliptin 5 mg, Drug: Vildagliptin 50 mg, Drug: Vildagliptin 50 mg BID, Drug: PlaceboSitagliptin 100 mg in Period 1 followed by vildagliptin 50 mg in Period 2 followed by saxagliptin 5 mg in Period 3 followed by placebo in Period 4 followed by vildagliptin 50 mg BID in Period 5
Treatment Sequence 7	Experimental	Drug: Sitagliptin 100 mg, Drug: Saxagliptin 5 mg, Drug: Vildagliptin 50 mg, Drug: Vildagliptin 50 mg BID, Drug: PlaceboSaxagliptin 5 mg in Period 1 followed by vildagliptin 50 mg BID in Period 2 followed by vildagliptin 50 mg in Period 3 followed by sitagliptin 100 mg in Period 4 followed by placebo in Period 5
Treatment Sequence 8	Experimental	Drug: Sitagliptin 100 mg, Drug: Saxagliptin 5 mg, Drug: Vildagliptin 50 mg, Drug: Vildagliptin 50 mg BID, Drug: PlaceboVildagliptin 50 mg in Period 1 followed by placebo in Period 2 followed by vildagliptin 50 mg BID in Period 3 followed by saxagliptin 5 mg in Period 4 followed by sitagliptin 100 mg in Period 5
Treatment Sequence 9	Experimental	Drug: Sitagliptin 100 mg, Drug: Saxagliptin 5 mg, Drug: Vildagliptin 50 mg, Drug: Vildagliptin 50 mg BID, Drug: PlaceboVildagliptin 50 mg BID in Period 1 followed by sitagliptin 100 mg in Period 2 followed by placebo in Period 3 followed by vildagliptin 50 mg in Period 4 followed by saxagliptin 5 mg in Period 5
Treatment Sequence 10	Experimental	Drug: Sitagliptin 100 mg, Drug: Saxagliptin 5 mg, Drug: Vildagliptin 50 mg, Drug: Vildagliptin 50 mg BID, Drug: PlaceboPlacebo in Period 1 followed by saxagliptin 5 mg in Period 2 followed by sitagliptin 100 mg in Period 3 followed by vildagliptin 50 mg BID in Period 4 followed by vildagliptin 50 mg in Period 5

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

female participants of reproductive potential must not be pregnant and agree to use (and/or have their partner use) two acceptable methods of birth control beginning at least 2 weeks prior to administration of the first dose of study drug until at least 2 weeks after the last administration of study drug
has a body mass index between 18 and 43 kg/m^2 inclusive
has a clinically confirmed diagnosis of T2DM
is not currently receiving any oral antihyperglycemic medications and has a screening visit hemoglobin A1c (HbA1c) between 6.5% and 10% inclusive
must not have been previously treated with a DPP-4 inhibitor or glucagon-like peptide-1 analogs within 12 weeks of prestudy visit

Key exclusion criteria (18 listed)

is mentally or legally incapacitated, has significant emotional problems at the time of prestudy visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 5 years
has an estimated creatinine clearance of ≤60 mL/min
has a history of stroke, chronic seizures, or major neurological disorder
has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases (with the exception of stable thyroid disease, T2DM and typical associated diseases such as hypertension and hyperlipidemia)
must not have been previously treated with any regimen that includes insulin (injected or inhaled) for at least 3 months

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
Sitagliptin 100 mgAlso: Januvia™Sitagliptin 100 mg: one sitagliptin 100 mg tablet once daily in the morning following a fast of at least approximately 8 hours on Days 1 through 5 in one out of five treatment periods.	Drug	Treatment Sequence 1, Treatment Sequence 10, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4, Treatment Sequence 5, Treatment Sequence 6, Treatment Sequence 7, Treatment Sequence 8, Treatment Sequence 9
Saxagliptin 5 mgAlso: Onglyza™Saxagliptin 5 mg: one saxagliptin 5 mg tablet once daily in the morning following a fast of at least approximately 8 hours on Days 1 through 5 in one out of five treatment periods.	Drug	Treatment Sequence 1, Treatment Sequence 10, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4, Treatment Sequence 5, Treatment Sequence 6, Treatment Sequence 7, Treatment Sequence 8, Treatment Sequence 9
Vildagliptin 50 mgAlso: Galvus™Vildagliptin 50 mg: one vildagliptin 50 mg tablet once daily in the morning following a fast of at least approximately 8 hours on Days 1 through 5 in one out of five treatment periods.	Drug	Treatment Sequence 1, Treatment Sequence 10, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4, Treatment Sequence 5, Treatment Sequence 6, Treatment Sequence 7, Treatment Sequence 8, Treatment Sequence 9
Vildagliptin 50 mg BIDAlso: Galvus™Vildagliptin 50 mg BID: one vildagliptin 50 mg tablet BID (twice daily), once in the morning following a fast of at least approximately 8 hours and once in the evening on Days 1 through 5 in one out of five treatment periods.	Drug	Treatment Sequence 1, Treatment Sequence 10, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4, Treatment Sequence 5, Treatment Sequence 6, Treatment Sequence 7, Treatment Sequence 8, Treatment Sequence 9
PlaceboPlacebo: one placebo for sitagliptin tablet once daily in the morning following a fast of at least approximately 8 hours on Days 1 through 5 in one out of five treatment periods.	Drug	Treatment Sequence 1, Treatment Sequence 10, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4, Treatment Sequence 5, Treatment Sequence 6, Treatment Sequence 7, Treatment Sequence 8, Treatment Sequence 9

Primary outcome

Percent Inhibition of Dipeptidyl Peptidase IV (DPP-4) Activity at Trough
Time frame: 24 hours following the final morning dose on Day 5
Percent inhibition of DPP-4 activity at 24 hours after the Day 5 morning dose (i.e., at trough) was determined by analysis of blood samples collected from the study participants.

4 secondary outcomes

Pharmacokinetic Analysis: Area Under the Curve 0-24 Hours (AUC 0-24hr)
Time frame: Predose (0 Hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20 and 24 hours after the morning dose on Day 5
Pharmacokinetic Analysis: Area Under the Curve 0-12 Hours (AUC 0-12hr) for Vildagliptin 50 mg BID
Time frame: Predose (0 hours) and 0.5, 1, 2, 4, 8 and 12 hours after the morning dose on Day 5
Pharmacokinetic Analysis: Peak Plasma Drug Concentration (Cmax)
Time frame: Predose (0 hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20, 24, 36, 48 and 96 hours after the morning dose on Day 5
Pharmacokinetic Analysis: Time to the Peak Plasma Drug Concentration (Tmax)
Time frame: Predose (0 hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20, 24, 36, 48 and 96 hours after the morning dose on Day 5

Results and safety

Results posted to the registry on 22 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence 1	2	2
Treatment Sequence 2	2	2
Treatment Sequence 3	2	2
Treatment Sequence 4	2	2
Treatment Sequence 5	3	3
Treatment Sequence 6	2	2
Treatment Sequence 7	3	2
Treatment Sequence 8	2	2
Treatment Sequence 9	2	2
Treatment Sequence 10	2	2

Primary outcome: Percent Inhibition of Dipeptidyl Peptidase IV (DPP-4) Activity at Trough

Time frame: 24 hours following the final morning dose on Day 5. Least squares mean (95% Confidence Interval). Unit: Percent inhibition

Measure	Sitagliptin 100 mg n = 17	Saxagliptin 5 mg n = 20	Vildagliptin 50 mg n = 18	Vildagliptin 50 mg BID n = 17	Placebo n = 17
Value	91.73 (91.37 to 92.08)	73.50 (66.56 to 79.00)	28.88 (17.90 to 38.38)	90.63 (88.93 to 92.06)	3.49 (-0.66 to 7.48)

Sitagliptin 100 mg vs Saxagliptin 5 mg: Least squares mean difference: 18.24 (90% CI 14.97 to 21.67), p <.001, Linear mixed effects model
Sitagliptin 100 mg vs Vildagliptin 50 mg: Least squares mean difference: 62.86 (90% CI 58.21 to 67.74), p <.001, Linear mixed effects model
Sitagliptin 100 mg vs Vildagliptin 50 mg BID: Least squares mean difference: 1.11 (90% CI -0.10 to 2.33), p = 0.128, Linear mixed effects model

Population analysed: All participants who had at least at least one measurement.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through approximately 14 days following the last dose of study drug in Period 5. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin 100 mg	0 of 20 (0%)	1 of 20 (5%)	Not reported
Saxagliptin 5 mg	0 of 21 (0%)	4 of 21 (19%)	Not reported
Vildagliptin 50 mg	0 of 18 (0%)	1 of 18 (5.6%)	Not reported
Vildagliptin 50 mg BID	0 of 19 (0%)	1 of 19 (5.3%)	Not reported
Placebo	0 of 21 (0%)	0 of 21 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24163113Tatosian DA, Guo Y, Schaeffer AK, Gaibu N, Popa S, Stoch A, Langdon RB, Kauh EA. Dipeptidyl peptidase-4 inhibition in patients with type 2 diabetes treated with saxagliptin, sitagliptin, or vildagliptin. Diabetes Ther. 2013 Dec;4(2):431-42. doi: 10.1007/s13300-013-0045-8. Epub 2013 Oct 26.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sitagliptin 100 mg, Saxagliptin 5 mg and Vildagliptin 50 mg in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

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 10 inclusion and 18 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 22 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Inhibition of Dipeptidyl Peptidase IV (DPP-4) Activity at Trough (time frame: 24 hours following the final morning dose on Day 5). 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 NCT01582308, 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 30 May 2017.