CompletedNCT03359590Updated Feb 21, 2021Results posted

Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients

A Phase 2 interventional study of Sitagliptin 100 mg and Placebo in Pharmacological Action, sponsored by Profil Institut für Stoffwechselforschung GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2021-02-21.

Sponsored by Profil Institut für Stoffwechselforschung GmbH · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 18 Years to 64 Years
Sex: All

Study summary

Sitagliptin, through its effects on sensitizing alpha-cell sensitivity to glucose, can initiate counter-regulatory glucagon responses at higher glycemic thresholds, thus reducing the number of clinically apparent hypoglycemic episodes, and/or ameliorating the severity of hypoglycemic episodes in the case that they should occur. The endpoints have defined such that consequences of this hypothesis can be measured.

Conditions studied

Pharmacological Action

In context

Lead sponsor

Profil Institut für Stoffwechselforschung GmbH is the lead sponsor of 26 studies on the registry; 1 is open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 64 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Male or female subject with diabetes mellitus type 2.
Age between 18 and 64 years, both inclusive.
\<= 8.5%.
Stable treatment with insulin glargine (any dose) and metformin (>= 1500 mg/day or at highest tolerated dose) for at least 3 months prior to inclusion into the trial with or without additional oral glucose-lowering agents (except thiazolidinediones).
Considered generally healthy (apart from diabetes mellitus type 2 and associated conditions such as hypertension, hyperlipidaemia and hyperuricaemia) upon completion of medical history, physical examination, vital signs, and analysis of laboratory safety variables, as judged by the Investigator.

Exclusion criteria

Exclusion Criteria:

Known or suspected to sitagliptin or related products.
More than one episode of severe hypoglycaemia with seizure, coma or requiring medical assistance of another person during the past 6 months or hypoglycaemic unawareness as judged by the Investigator.
Current or previous treatment (less than 3 months prior to screening) with insulin products other than insulin glargine and/or with Glucagon-like peptide (GLP) 1 receptor agonists and/or with thiazolidinediones.
Unwillingness to wash-off any oral glucose-lowering agents other than metformin.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c: A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
ECG (electrocardiogram): A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Hypersensitivity: An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 20 participants (actual)

Study arms

Experimental
Sitagliptin arm
Sitagliptin 100 mg
Drug: Sitagliptin 100 mg
Placebo comparator
Placebo arm
Placebo comparator
Drug: Placebo

Interventions

DrugSitagliptin 100 mg
The treatment consists of sitagliptin tablets (100 mg/day) for up to 24 weeks.
DrugPlacebo
The treatment consists of placebo tablets for up to 24 weeks.

What researchers measure

Primary outcomes

The Frequency of Hypoglycaemic Episodes With Sitagliptin vs Placebo Treatment.
The purpose of the trial was to test the influence of DPP-4 inhibition on the risk to develop hypoglycaemia. Chemical hypoglycaemic episodes (characterised by a plasma glucose nadir ≤70 mg/dL) occurring during the in-house periods of the subjects were compared.
Time frame: during the two in-house periods (54 hs each) after treatment with sitagliptin or placebo for up to 24 weeks

Results

Posted Feb 21, 2021

Participant flow

Subjects were recruited by use of the site specific database

First Intervention

Participant flow — First Intervention
Milestone	Sequence 1	Sequence 2
Started	10	10
Exposed	9	10
Discontinued	1	2
Completed	9	8
Not completed	1	2
Withdrew: Withdrawal by subject	1	1
Withdrew: Protocol violation	0	1

Second Intervention

Participant flow — Second Intervention
Milestone	Sequence 1	Sequence 2
Started	9	8
Exposed	9	8
Discontinued	0	0
Completed	9	8
Not completed	0	0

Outcome measures

PrimaryThe Frequency of Hypoglycaemic Episodes With Sitagliptin vs Placebo Treatment.

The purpose of the trial was to test the influence of DPP-4 inhibition on the risk to develop hypoglycaemia. Chemical hypoglycaemic episodes (characterised by a plasma glucose nadir ≤70 mg/dL) occurring during the in-house periods of the subjects were compared.

Time frame:: during the two in-house periods (54 hs each) after treatment with sitagliptin or placebo for up to 24 weeks
Reported as:: Mean · Hypoglycaemic episodes

The Frequency of Hypoglycaemic Episodes With Sitagliptin vs Placebo Treatment.
Hypoglycaemic episodes	Sitagliptin Arm	Placebo Arm
The Frequency of Hypoglycaemic Episodes With Sitagliptin vs Placebo Treatment.	5.35 ± 4.137	5.72 ± 3.045

Adverse events

Collected over For each participant from baseline to end of trial, with a range from 7-53 weeks per participant, on average 11 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Sitagliptin Arm	0/17 (0%)	0/17 (0%)	12/17 (70.6%)
Placebo Arm	0/19 (0%)	1/19 (5.3%)	11/19 (57.9%)

Most frequent serious events

Most frequent serious events
Event	Sitagliptin Arm	Placebo Arm
Coronary heart dieseaseCardiac disorders	0/17	1/19

Most frequent other events

Showing 10 of 27

Most frequent other events
Event	Sitagliptin Arm	Placebo Arm
HeadacheNervous system disorders	6/17	3/19
DiarrhoeaGastrointestinal disorders	1/17	4/19
NauseaGastrointestinal disorders	3/17	1/19
VomitingGastrointestinal disorders	2/17	2/19
Arthropod biteInjury, poisoning and procedural complications	2/17	1/19
ArthralgiaMusculoskeletal and connective tissue disorders	1/17	2/19
TachyarrhythmiaCardiac disorders	1/17	0/19
Infusion site thrombosisInjury, poisoning and procedural complications	1/17	0/19
Traumatic amputationInjury, poisoning and procedural complications	1/17	0/19
Muscle contractions involuntaryMusculoskeletal and connective tissue disorders	1/17	0/19

Baseline characteristics

Participants of both arms are included here

Age, Categorical
Age, Categorical(Participants)	All Study Participants
<=18 years	0
Between 18 and 65 years	20
>=65 years	0

Sex: Female, Male
Sex: Female, Male(Participants)	All Study Participants
Female	5
Male	15

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	All Study Participants
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	20
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	All Study Participants
Germany	20

Body mass index (BMI, kg/m2)
Body mass index (BMI, kg/m2)(kg/m^2)	All Study Participants
Mean	29.19 ± 4.139

Waist circumference (cm)
Waist circumference (cm)(cm)	All Study Participants
Mean	105.9 ± 9.02

Height (cm)
Height (cm)(cm)	All Study Participants
Mean	178.1 ± 9.20

Weight (kg)
Weight (kg)(kg)	All Study Participants
Mean	92.32 ± 13.79

1 further baseline measures are reported on the registry.

Study locations

1 site

Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Jan 22, 2018

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Jul 2019, 15 months.

Results were first posted in Feb 2021, 1 year 7 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 24, 2017
First posted: Dec 2, 2017
StartActual: Mar 21, 2018
Primary completionActual: Jul 17, 2019
CompletionActual: Jul 17, 2019
Results first posted: Feb 21, 2021
Last update: Feb 21, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03359590
Lead sponsor: Profil Institut für Stoffwechselforschung GmbH
Collaborators: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Dec 2, 2017
Start date: Mar 21, 2018
Primary completion: Jul 17, 2019
Completion: Jul 17, 2019
Results posted: Feb 21, 2021
Last update: Feb 21, 2021

Study contacts

Christoph Kapitza, MD

principal investigator · Profil GmbH

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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