Diabetes Mellitus Type 2Phase 4NCT02373865
Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes
A Phase 4 study testing Sitagliptin and Glimepiride in people with Diabetes Mellitus Type 2, run by GWT-TUD GmbH at 1 site in Germany.
Trial summary
This exploratory double blind randomized active controlled study is designed to assess the effects of a treatment with therapeutical dosage of sitagliptin versus therapeutical dosage of glimepiride as add on therapy in patients with diabetes mellitus type 2 (T2DM) patients inadequately controlled on metformin… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Sitagliptin and Glimepiride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Jan 2017
- Phase
- Phase 4
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- age 40-80 years
- stable dose of ≥ 1500 mg metformin or maximal tolerated dose of metformin for > 6 weeks
- HbA1c ≥ 7 % - ≤ 9.0% for age < 65 years and ≥ 7.5 % - ≤ 9.0% for age ≥ 65 years
- able and trained to perform SMBG
- the informed consent form must be signed before any study specific tests or procedures are done
- ability to understand and follow study-related instructions
Who cannot join
- Type 1 diabetes
- previous treatment with insulin, GLP1 analogues and SU in < 6 month
- HbA1c > 9 % or FPG > 15 mmol/l at randomization
- renal impairment with eGFR < 60 ml/min
- medical history of severe hypoglycemia defined as necessity of medical assistance in < 1 year
- major cardiovascular event (MACE) in medical history < 6 months
Show all 15Show fewer
- preexisting atrial fibrillation, , AV block ≥II degree, pace-maker, implanted defibrillator
- major cardiovascular event in medical history < 6 months
- heart failure NYHA ≥ III
- contraindications to glimepiride and sitagliptin or to any excipients according to product information
- severe cognitive deficits
- Patients who are disable to read and understand informative aspects of the trial
- Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s)
- Inability to comply with study procedures
- Pregnant or breast-feeding woman and woman without adequate method of contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double Blind Parallel Design Study Comparing Risk of Nocturnal Hypoglycemia and Critical Arrhythmia With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes Insufficiently Controlled With Metformin Monotherapy
This exploratory double blind randomized active controlled study is designed to assess the effects of a treatment with therapeutical dosage of sitagliptin versus therapeutical dosage of glimepiride as add on therapy in patients with diabetes mellitus type 2 (T2DM) patients inadequately controlled on metformin monotherapy.
Read the detailed description
Type 2 Diabetes is associated with an increased cardiovascular morbidity and mortality. Among patients insufficiently controlled with metformin multimorbidity and polypharmacy is common that makes the patients frail for cardiovascular complications related to hypoglycemic events.
This exploratory double blind randomized active controlled study is designed to assess the effects of a treatment with therapeutical dosage of sitagliptin versus therapeutical dosage of glimepiride as add on therapy in patients with T2DM patients inadequately controlled on metformin monotherapy.
Examinations will be performed as a 5 day recording of subcutaneous glucose concentration (CGMS) and holder ECG (AMEDTEC) at baseline and after a 12 weeks treatment with sitagliptin or glimepiride as active comparators used in combination with metformin.
With recording of nocturnal hypoglycemia and arrhythmias it is aimed to evaluate favorable glycemic profile under treatment with sitagliptin compared to glimepiride. The primary objective is risk of serious HE for both drugs.
The glycemic profile of sitagliptin as add-on therapy to metformin seems to be favorable compared to sulfonylureass such as glimepiride. Treatment with sitagliptin as add-on to metformin therapy causes less glycemic fluctuations and may be associated with lower oxidative stress and down regulation of low grade inflammation. This hypothesis will be tested as an explorative double blind study.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Sitagliptin, Glimepiride, Sitagliptin-Placebo, Glimepiride-Placebo
- Keywords
- Diabetes mellitus type 2, nocturnal hypoglycemia, metformin monotherapy
- 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
Sitagliptin will be given in a daily dosage of 100 mg
GlimepirideDrug
Glimepiride will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg
Sitagliptin-PlaceboDrug
Sitagliptin-Placebo will be given additional to Glimepiride (blinded). It will be given in a daily dosage of 100 mg
Glimepiride-PlaceboDrug
Glimepiride-Placebo will be given additional to Sitagliptin (blinded). It will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Patients receiving Sitagliptin 100 mg+ Glimepiride-placebo (adapted dosage) Receives: Drug: Sitagliptin; Drug: Glimepiride-Placebo |
| Arm B | Active comparator | Glimepiride (adapted dosage) + Sitagliptin 100 mg Placebo Receives: Drug: Glimepiride; Drug: Sitagliptin-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Hypoglycemic Episodes (HE) Under Treatment With Sitagliptin Compared to Glimepiride
measurement of hypoglycemic episodes including event duration at baseline and EOT after 12 weeks of treatment and measurement of time spent below critical values for hypoglycemic episodes are the primary objectives of this study. We will calculate overall episodes/time (5 days) and nocturnal episodes.
Measured: 12 weeks (at baseline and at EOT)
Secondary outcomes (2)
Occurence and Number of Nocturnal Ventricular Arrhythmias
measurement of nocturnal ventricular arrhythmias at baseline and EOT (after 12 weeks of treatment) - per patient, couplets per patient, triplets per patient)
Measured: 12 weeks (at baseline and at EOT)
Glycemic Variability (Profile) of Sitagliptin Compared to Glimepiride
The glycemic profile is defined as the area under the glucose-timeprofile obtained by continuous glucose monitoring (5 days baseline and 5 days after 12 weeks of each treatment)
Measured: 12 weeks (at baseline and at EOT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Premature termination due to insufficient patient recruitement..
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.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- GWT-TUD GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markolf Hanefeld, Prof. Dr., Study director, GWT-TUD GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373865
- Sponsor's protocol ID
- DIA-2-REDESIGN
- Status last verified
- Oct 2018
- First submitted
- 8 Jan 2015
- Last updated
- 27 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Parallel Design Study Comparing Risk of Nocturnal Hypoglycemia and Critical Arrhythmia With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes Insufficiently Controlled With Metformin Monotherapy
- ClinicalTrials.gov ID
- NCT02373865
- Acronym / sponsor ID
- DIA-2-REDESIGN
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Diabetes mellitus type 2, nocturnal hypoglycemia, metformin monotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Premature termination due to insufficient patient recruitement..
- Enrolment
- 4 participants (actual)
- Lead sponsor
- GWT-TUD GmbHUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Posted 27 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This exploratory double blind randomized active controlled study is designed to assess the effects of a treatment with therapeutical dosage of sitagliptin versus therapeutical dosage of glimepiride as add on therapy in patients with diabetes mellitus type 2 (T2DM) patients inadequately controlled on metformin monotherapy.
Detailed description
Type 2 Diabetes is associated with an increased cardiovascular morbidity and mortality. Among patients insufficiently controlled with metformin multimorbidity and polypharmacy is common that makes the patients frail for cardiovascular complications related to hypoglycemic events.
This exploratory double blind randomized active controlled study is designed to assess the effects of a treatment with therapeutical dosage of sitagliptin versus therapeutical dosage of glimepiride as add on therapy in patients with T2DM patients inadequately controlled on metformin monotherapy.
Examinations will be performed as a 5 day recording of subcutaneous glucose concentration (CGMS) and holder ECG (AMEDTEC) at baseline and after a 12 weeks treatment with sitagliptin or glimepiride as active comparators used in combination with metformin.
With recording of nocturnal hypoglycemia and arrhythmias it is aimed to evaluate favorable glycemic profile under treatment with sitagliptin compared to glimepiride. The primary objective is risk of serious HE for both drugs.
The glycemic profile of sitagliptin as add-on therapy to metformin seems to be favorable compared to sulfonylureass such as glimepiride. Treatment with sitagliptin as add-on to metformin therapy causes less glycemic fluctuations and may be associated with lower oxidative stress and down regulation of low grade inflammation. This hypothesis will be tested as an explorative double blind study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Sitagliptin, Drug: Glimepiride-PlaceboPatients receiving Sitagliptin 100 mg+ Glimepiride-placebo (adapted dosage) |
| Arm B | Active comparator | Drug: Glimepiride, Drug: Sitagliptin-PlaceboGlimepiride (adapted dosage) + Sitagliptin 100 mg Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- type 2 diabetes
- age 40-80 years
- stable dose of ≥ 1500 mg metformin or maximal tolerated dose of metformin for > 6 weeks
- HbA1c ≥ 7 % - ≤ 9.0% for age < 65 years and ≥ 7.5 % - ≤ 9.0% for age ≥ 65 years
- able and trained to perform SMBG
Key exclusion criteria (15 listed)
- Type 1 diabetes
- previous treatment with insulin, GLP1 analogues and SU in < 6 month
- HbA1c > 9 % or FPG > 15 mmol/l at randomization
- renal impairment with eGFR < 60 ml/min
- medical history of severe hypoglycemia defined as necessity of medical assistance in < 1 year
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 |
|---|---|---|
| SitagliptinSitagliptin will be given in a daily dosage of 100 mg | Drug | Arm A |
| GlimepirideGlimepiride will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg | Drug | Arm B |
| Sitagliptin-PlaceboSitagliptin-Placebo will be given additional to Glimepiride (blinded). It will be given in a daily dosage of 100 mg | Drug | Arm B |
| Glimepiride-PlaceboGlimepiride-Placebo will be given additional to Sitagliptin (blinded). It will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg | Drug | Arm A |
Primary outcome
Number of Hypoglycemic Episodes (HE) Under Treatment With Sitagliptin Compared to Glimepiride
Time frame: 12 weeks (at baseline and at EOT)
measurement of hypoglycemic episodes including event duration at baseline and EOT after 12 weeks of treatment and measurement of time spent below critical values for hypoglycemic episodes are the primary objectives of this study. We will calculate overall episodes/time (5 days) and nocturnal episodes.
2 secondary outcomes
Occurence and Number of Nocturnal Ventricular Arrhythmias
Time frame: 12 weeks (at baseline and at EOT)
Glycemic Variability (Profile) of Sitagliptin Compared to Glimepiride
Time frame: 12 weeks (at baseline and at EOT)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus Type 2
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.
Markolf Hanefeld, Prof. Dr. study director
GWT-TUD GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sitagliptin and Glimepiride in people with Diabetes Mellitus Type 2, run by GWT-TUD GmbH at 1 site in Germany.
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 7 inclusion and 15 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: stopped early, as of the sponsor's last update on 27 Feb 2019. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 27 Feb 2019). 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?
Number of Hypoglycemic Episodes (HE) Under Treatment With Sitagliptin Compared to Glimepiride (time frame: 12 weeks (at baseline and at EOT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2019.