Type 2 DiabetesPhase 1NCT02749032
Feed-Back Suppression of Meal-Induced Glucagon-like Peptide 1 (GLP-1) Secretion
A Phase 1 study testing Mixed meal test, Vildagliptin and Sitagliptin in people with Type 2 Diabetes, run by Michael A. Nauck at 1 site in Germany.
Trial summary
The present study is a phase I, single-centre, double-blind, randomized, cross-over (3 treatments, 3 treatment periods and 6 sequences), stratified (background medication: metformin vs. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Mixed meal test, Vildagliptin and Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Mar 2014
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetes mellitus type 2 for more than one year, as defined by the American Diabetes Association
- body-mass-index between 20.0 and 40.0 kg/m² (inclusive),
- glycohaemoglobin (HbA1c) ≤ 8.5%,
- normal vital signs after 10 minutes resting in the supine position: systolic blood pressure 96 mmHg -159 mmHg; diastolic blood pressure 46 mmHg-99 mmHg; heart rate 46-99 bpm
- laboratory parameters within the normal range, or abnormalities judged to be clinically irrelevant by the investigator (serum estimated glomerular filtration rate was enforced to be > 60 ml/min; hepatic enzymes and bilirubin (unless the subject has documented Gilbert syndrome) had to be > 3-fold the upper limit of normal)
- women of childbearing potential (less than two years post-menopausal or not surgically sterile for more than 3 months), had to prove a negative serum β-human chorionic gonadotropin (HCG) pregnancy test at screening and a negative urine β-HCG pregnancy test at day 1 on each of the treatment periods, had to use a highly effective method of birth control (failure rate less than 1% per year)
- normal or clinically irrelevant findings in medical history and physical examination
Who cannot join
- any glucose-lowering drug therapy other than metformin during 3 months before the first treatment period
- any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 2), haematological, neurological, psychiatric, systemic, ocular, gynaecologic, or infectious disease; any acute infectious disease or signs of acute illness
- symptoms of a clinically significant illness in the 3 months before the study, which, according to the investigator's opinion, could interfere with the purposes of the study
- congestive heart failure of New York Heart Association (NYHA) functional class III-IV
- Regular use of any medication other than metformin in the last month before study start with the exception of thyroid hormones, lipid-lowering and antihypertensive drugs, and, if female, with the exception of hormonal contraception or menopausal hormone replacement therapy
- blood loss (>300 ml, any reason) within 3 months before inclusion, or a haemoglobin < 11.0 g/dl
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- participation in a trial with any investigational drug during the past three months
- presence or history of a drug allergy or clinically significant allergic disease according to the investigator's judgment including any known hypersensitivity to DPP-4 inhibitors
- presence of drug or alcohol abuse (alcohol consumption > 40 grams / day)
- if female, pregnancy (defined as positive β-HCG blood test), breast-feeding
Trial locations and contacts
1 site in 1 country.
Germany1 site
Diabeteszentrum Bad Lauterberg
Bad Lauterberg im Harz, Lower Saxony, 37431
About this study
Official title: Feed-Back Suppression of Meal-Induced GLP-1 Secretion Mediated Through Elevations in Intact GLP-1 Caused by Dipeptidyl Peptidase 4 (DPP-4) Inhibition: A Randomized, Prospective Comparison of Sitagliptin and Vildagliptin Treatment
The present study is a phase I, single-centre, double-blind, randomized, cross-over (3 treatments, 3 treatment periods and 6 sequences), stratified (background medication: metformin vs. diet-only), placebo-controlled study, comparing periods lasting 6-9 days on treatment with repeated doses of vildagliptin, sitagliptin, or placebo, with wash-out periods between treatment periods lasting 21 days minimum.
The study was designed to directly compare the effects of vildagliptin and sitagliptin on incretin hormone responses, glycaemia, and insulin as well as glucagon secretory responses in patients with type 2 diabetes.
Read the detailed description
Design. The present study is a phase I, single-centre, double-blind, randomized, cross-over (3 treatments, 3 treatment periods and 6 sequences), stratified (background medication: metformin vs. diet-only), placebo-controlled study, comparing periods lasting 6-9 days on treatment with repeated doses of vildagliptin, sitagliptin, or placebo, with wash-out periods between treatment periods lasting 21 days minimum.
Experimental procedures. Meal tests were performed in the morning after an overnight fast. The standardized mixed meal was composed of 2 eggs (100 g), 1 slice (50 g) of whole grain rye bread, 1 slice (50 g) of rye flour bread, 10 g of fat-reduced margarine, 20 g of boiled ham, and 25 g of diet jam, amounting to 450 kcal, 50 % carbohydrate, 20 % protein, and 30 % fat (based on calorie count). Patients were allowed to drink tea (black or fruit-based) or de-caffeinated coffee ad libitum.
Blood sampling. Plasma glucose was determined in capillary samples taken from hyperaemic ear lobes. Venous blood was collected from indwelling venous cannulas placed in a distal forearm vein, for the determination of insulin, C-peptide, glucagon, GLP-1 (total), GLP-1 (intact), glucose-dependent insulinotropic polypeptide (GIP) (total), GIP (intact), and free fatty acids. After drawing basal blood specimens at -15 and 0 min, blood was taken at 15, 30, 45, 60, 90, 120, 180, and 240 min.
Laboratory determinations. Glucose, insulin, C-peptide, total GLP-1 (C-terminally directed assay), intact GLP-1 (sandwich ELISA), total GIP (C-terminally directed assay), intact GIP (N-terminally directed assay) and glucagon were determined.
- Conditions
- Type 2 Diabetes
- Being tested
- Mixed meal test, Vildagliptin, Sitagliptin, Placebo, Metformin
- 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.
Mixed meal testOther
Mixed meal test were performed in the morning after an overnight fast. The standardized mixed meal was composed of 2 eggs (100 g), 1 slice (50 g) of whole grain rye bread, 1 slice (50 g) of rye flour bread, 10 g of fat-reduced margarine, 20 g of boiled ham, and 25 g of diet jam, amounting to 450 kcal, 50 % carbohydrate, 20 % protein, and 30 % fat (based on calorie count). Patients were allowed to drink tea (black or fruit-based) or de-caffeinated coffee ad libitum.
VildagliptinDrug
Vildagliptin (50 mg per tablet) was administered orally twice daily (15 minutes prior to breakfast or test meal, on the last day of treatment period) and without a defined temporal relation to dinner in the evening, irrespective of the stratum defined by the background diabetes treatment.
SitagliptinDrug
The dosage of sitagliptin depended on the stratum defined by the background diabetes medication. In patients treated with diet and exercise (no other glucose-.lowering medication), sitagliptin was given as one 100 mg in the morning (15 minutes prior to breakfast or the test meal, on the last day of the treatment period), and a corresponding placebo tablet was administered in the evening (no temporal relation to dinner required).
PlaceboDrug
Placebo was administered orally twice daily: 15 minutes prior to breakfast or the test meal on the last day of treatment period) and one dose in the evening (no temporal relation to dinner required).
MetforminDrug
For patients continuing with pre-existing metformin treatment, 1000 mg film coated tablets from commercial sources. In half of the patients (stratum: metformin as background medication), metformin was administered orally twice daily at 1000 mg of active compound during of after breakfast and dinner.
Diet and exerciseOther
Patients treated their diabetes mellitus type 2 with diet/exercise only
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin - stratum diet/exercise | Active comparator | Vildagliptin (50 mg per tablet) was administered orally twice daily (15 minutes prior to breakfast or test meal, on the last day of treatment period) and without a defined temporal relation to dinner in the evening, irrespective of the stratum defined by the background diabetes treatment.
Mixed meal test were performed in the morning after an overnight fast. Receives: Other: Mixed meal test; Drug: Vildagliptin; Other: Diet and exercise |
| Vildagliptin - stratum metformin | Active comparator | Vildagliptin (50 mg per tablet) was administered orally twice daily (15 minutes prior to breakfast or test meal, on the last day of treatment period) and without a defined temporal relation to dinner in the evening, irrespective of the stratum defined by the background diabetes treatment.
Mixed meal test were performed in the morning after an overnight fast. Receives: Other: Mixed meal test; Drug: Vildagliptin; Drug: Metformin |
| Sitagliptin - stratum diet/exercise | Active comparator | The dosage of sitagliptin depended on the stratum defined by the background diabetes medication. In patients treated with diet and exercise (no other glucose-.lowering medication), sitagliptin was given as one 100 mg in the morning (15 minutes prior to breakfast or the test meal, on the last day of the treatment period), and a corresponding placebo tablet was administered in the evening (no temporal relation to dinner required).
Mixed meal test were performed in the morning after an overnight fast. Receives: Other: Mixed meal test; Drug: Sitagliptin; Other: Diet and exercise |
| Sitagliptin - stratum metformin | Active comparator | In patients treated with metformin, sitagliptin (50 mg per tablet) was administered orally twice daily (15 minutes prior to breakfast or test meal, on the last day of treatment period) and without a defined temporal relation to dinner in the evening.
Mixed meal test were performed in the morning after an overnight fast. Receives: Other: Mixed meal test; Drug: Sitagliptin; Drug: Metformin |
| Placebo - stratum diet/exercise | Placebo comparator | Placebo was administered orally twice daily: 15 minutes prior to breakfast or the test meal on the last day of treatment period) and one dose in the evening (no temporal relation to dinner required).
Mixed meal test were performed in the morning after an overnight fast. Receives: Other: Mixed meal test; Drug: Placebo; Other: Diet and exercise |
| Placebo - stratum metformin | Placebo comparator | Placebo was administered orally twice daily: 15 minutes prior to breakfast or the test meal on the last day of treatment period) and one dose in the evening (no temporal relation to dinner required).
Mixed meal test were performed in the morning after an overnight fast. Receives: Other: Mixed meal test; Drug: Placebo; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-1 feedback inhibition
Comparison of the percentage reduction or its reciprocal value (times 100) in total GLP-1 (secretion, incremental values above baseline, 0-240 min following meal ingestion) between vildagliptin and sitagliptin treatment relative to placebo treatment.
Measured: 0-240 min following meal ingestion
Secondary outcomes (6)
Relationship of the GLP-1 feedback inhibition [%]
Relationship of the GLP-1 feedback inhibition [%] by DPP-4 inhibition to meal-related plasma responses of "total" and "intact" incretin hormone concentrations
Measured: 0-240 min following meal ingestion
Differences in glucagon secretion [pmol/l]
Differences in glucagon secretion [pmol/l] between vildagliptin and sitagliptin treatment relative to placebo treatment during mixed meal tests
Measured: 0-240 min following meal ingestion
Differences in insulin secretory responses - Insulin [pmol/l]
Differences in insulin secretory responses due to insulin concentration between vildagliptin and sitagliptin treatment relative to placebo [pmol/l] treatment during mixed meal tests
Measured: 0-240 min following meal ingestion
Differences in insulin secretory responses - c-peptide [pmol/l]
Differences in insulin secretory responses due to c-peptide [pmol/l] concentration between vildagliptin and sitagliptin treatment relative to placebo treatment during mixed meal tests
Measured: 0-240 min following meal ingestion
Differences in glucose concentrations [mmol/l]
Differences in glucose concentrations [mmol/l] between vildagliptin and sitagliptin treatment relative to placebo treatment during mixed meal tests
Measured: 0-240 min following meal ingestion
Incidence of Treatment-Emergent Adverse Events - Safety and tolerability
Safety and tolerability of treatments were assessed for A) period between screening visit and first treatment period (3 to 28 days),B) Three treatment periods 7 to 9 days each (21 - 28 days),C) 2 wash-out periods between 21 - 40 days (42 - 80 days), and D) Period between last treatment visit and end of study visit (1 day). In total that are 67 - 136 days (2.2 - 4.7 month). Patients were ask for any adverse events. Incidence of Treatment-Emergent Adverse Events were analysed.
Measured: From date of screening until the end of study date, assessed for up to 4.7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startNov 2011
- Primary completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael A. Nauck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael A. Nauck, Diabeteszentrum Bad Lauterberg im Harz
- Investigators
- Michael A. Nauck, Prof., Principal investigator, Diabeteszentrum Bad Lauterberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749032
- Sponsor's protocol ID
- DZBL-2010-1
- Status last verified
- Apr 2016
- First submitted
- 8 Apr 2016
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feed-Back Suppression of Meal-Induced GLP-1 Secretion Mediated Through Elevations in Intact GLP-1 Caused by Dipeptidyl Peptidase 4 (DPP-4) Inhibition: A Randomized, Prospective Comparison of Sitagliptin and Vildagliptin Treatment
- ClinicalTrials.gov ID
- NCT02749032
- Acronym / sponsor ID
- DZBL-2010-1
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Michael A. NauckUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2014 (actual)
- First posted
- 22 Apr 2016 (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.
The present study is a phase I, single-centre, double-blind, randomized, cross-over (3 treatments, 3 treatment periods and 6 sequences), stratified (background medication: metformin vs. diet-only), placebo-controlled study, comparing periods lasting 6-9 days on treatment with repeated doses of vildagliptin, sitagliptin, or placebo, with wash-out periods between treatment periods lasting 21 days minimum.
The study was designed to directly compare the effects of vildagliptin and sitagliptin on incretin hormone responses, glycaemia, and insulin as well as glucagon secretory responses in patients with type 2 diabetes.
Detailed description
Design. The present study is a phase I, single-centre, double-blind, randomized, cross-over (3 treatments, 3 treatment periods and 6 sequences), stratified (background medication: metformin vs. diet-only), placebo-controlled study, comparing periods lasting 6-9 days on treatment with repeated doses of vildagliptin, sitagliptin, or placebo, with wash-out periods between treatment periods lasting 21 days minimum.
Experimental procedures. Meal tests were performed in the morning after an overnight fast. The standardized mixed meal was composed of 2 eggs (100 g), 1 slice (50 g) of whole grain rye bread, 1 slice (50 g) of rye flour bread, 10 g of fat-reduced margarine, 20 g of boiled ham, and 25 g of diet jam, amounting to 450 kcal, 50 % carbohydrate, 20 % protein, and 30 % fat (based on calorie count). Patients were allowed to drink tea (black or fruit-based) or de-caffeinated coffee ad libitum.
Blood sampling. Plasma glucose was determined in capillary samples taken from hyperaemic ear lobes. Venous blood was collected from indwelling venous cannulas placed in a distal forearm vein, for the determination of insulin, C-peptide, glucagon, GLP-1 (total), GLP-1 (intact), glucose-dependent insulinotropic polypeptide (GIP) (total), GIP (intact), and free fatty acids. After drawing basal blood specimens at -15 and 0 min, blood was taken at 15, 30, 45, 60, 90, 120, 180, and 240 min.
Laboratory determinations. Glucose, insulin, C-peptide, total GLP-1 (C-terminally directed assay), intact GLP-1 (sandwich ELISA), total GIP (C-terminally directed assay), intact GIP (N-terminally directed assay) and glucagon were determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin - stratum diet/exercise | Active comparator | Other: Mixed meal test, Drug: Vildagliptin, Other: Diet and exerciseVildagliptin (50 mg per tablet) was administered orally twice daily (15 minutes prior to breakfast or test meal, on the last day of treatment period) and without a defined temporal relation to dinner in the evening, irrespective of the stratum defined by the background diabetes treatment. Mixed meal test were performed in the morning after an overnight fast. |
| Vildagliptin - stratum metformin | Active comparator | Other: Mixed meal test, Drug: Vildagliptin, Drug: MetforminVildagliptin (50 mg per tablet) was administered orally twice daily (15 minutes prior to breakfast or test meal, on the last day of treatment period) and without a defined temporal relation to dinner in the evening, irrespective of the stratum defined by the background diabetes treatment. Mixed meal test were performed in the morning after an overnight fast. |
| Sitagliptin - stratum diet/exercise | Active comparator | Other: Mixed meal test, Drug: Sitagliptin, Other: Diet and exerciseThe dosage of sitagliptin depended on the stratum defined by the background diabetes medication. In patients treated with diet and exercise (no other glucose-.lowering medication), sitagliptin was given as one 100 mg in the morning (15 minutes prior to breakfast or the test meal, on the last day of the treatment period), and a corresponding placebo tablet was administered in the evening (no temporal relation to dinner required). Mixed meal test were performed in the morning after an overnight fast. |
| Sitagliptin - stratum metformin | Active comparator | Other: Mixed meal test, Drug: Sitagliptin, Drug: MetforminIn patients treated with metformin, sitagliptin (50 mg per tablet) was administered orally twice daily (15 minutes prior to breakfast or test meal, on the last day of treatment period) and without a defined temporal relation to dinner in the evening. Mixed meal test were performed in the morning after an overnight fast. |
| Placebo - stratum diet/exercise | Placebo comparator | Other: Mixed meal test, Drug: Placebo, Other: Diet and exercisePlacebo was administered orally twice daily: 15 minutes prior to breakfast or the test meal on the last day of treatment period) and one dose in the evening (no temporal relation to dinner required). Mixed meal test were performed in the morning after an overnight fast. |
| Placebo - stratum metformin | Placebo comparator | Other: Mixed meal test, Drug: Placebo, Drug: MetforminPlacebo was administered orally twice daily: 15 minutes prior to breakfast or the test meal on the last day of treatment period) and one dose in the evening (no temporal relation to dinner required). Mixed meal test were performed in the morning after an overnight fast. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- diabetes mellitus type 2 for more than one year, as defined by the American Diabetes Association
- body-mass-index between 20.0 and 40.0 kg/m² (inclusive),
- glycohaemoglobin (HbA1c) ≤ 8.5%,
- normal vital signs after 10 minutes resting in the supine position: systolic blood pressure 96 mmHg -159 mmHg; diastolic blood pressure 46 mmHg-99 mmHg; heart rate 46-99 bpm
- laboratory parameters within the normal range, or abnormalities judged to be clinically irrelevant by the investigator (serum estimated glomerular filtration rate was enforced to be > 60 ml/min; hepatic enzymes and bilirubin (unless the subject has documented Gilbert syndrome) had to be > 3-fold the upper limit of normal)
Key exclusion criteria (10 listed)
- any glucose-lowering drug therapy other than metformin during 3 months before the first treatment period
- any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 2), haematological, neurological, psychiatric, systemic, ocular, gynaecologic, or infectious disease; any acute infectious disease or signs of acute illness
- symptoms of a clinically significant illness in the 3 months before the study, which, according to the investigator's opinion, could interfere with the purposes of the study
- congestive heart failure of New York Heart Association (NYHA) functional class III-IV
- Regular use of any medication other than metformin in the last month before study start with the exception of thyroid hormones, lipid-lowering and antihypertensive drugs, and, if female, with the exception of hormonal contraception or menopausal hormone replacement therapy
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 |
|---|---|---|
| Mixed meal testMixed meal test were performed in the morning after an overnight fast. The standardized mixed meal was composed of 2 eggs (100 g), 1 slice (50 g) of whole grain rye bread, 1 slice (50 g) of rye flour bread, 10 g of fat-reduced margarine, 20 g of boiled ham, and 25 g of diet jam, amounting to 450 kcal, 50 % carbohydrate, 20 % protein, and 30 % fat (based on calorie count). Patients were allowed to drink tea (black or fruit-based) or de-caffeinated coffee ad libitum. | Other | Placebo - stratum diet/exercise, Placebo - stratum metformin, Sitagliptin - stratum diet/exercise, Sitagliptin - stratum metformin, Vildagliptin - stratum diet/exercise, Vildagliptin - stratum metformin |
| VildagliptinVildagliptin (50 mg per tablet) was administered orally twice daily (15 minutes prior to breakfast or test meal, on the last day of treatment period) and without a defined temporal relation to dinner in the evening, irrespective of the stratum defined by the background diabetes treatment. | Drug | Vildagliptin - stratum diet/exercise, Vildagliptin - stratum metformin |
| SitagliptinThe dosage of sitagliptin depended on the stratum defined by the background diabetes medication. In patients treated with diet and exercise (no other glucose-.lowering medication), sitagliptin was given as one 100 mg in the morning (15 minutes prior to breakfast or the test meal, on the last day of the treatment period), and a corresponding placebo tablet was administered in the evening (no temporal relation to dinner required). | Drug | Sitagliptin - stratum diet/exercise, Sitagliptin - stratum metformin |
| PlaceboPlacebo was administered orally twice daily: 15 minutes prior to breakfast or the test meal on the last day of treatment period) and one dose in the evening (no temporal relation to dinner required). | Drug | Placebo - stratum diet/exercise, Placebo - stratum metformin |
| MetforminFor patients continuing with pre-existing metformin treatment, 1000 mg film coated tablets from commercial sources. In half of the patients (stratum: metformin as background medication), metformin was administered orally twice daily at 1000 mg of active compound during of after breakfast and dinner. | Drug | Placebo - stratum metformin, Sitagliptin - stratum metformin, Vildagliptin - stratum metformin |
| Diet and exercisePatients treated their diabetes mellitus type 2 with diet/exercise only | Other | Placebo - stratum diet/exercise, Sitagliptin - stratum diet/exercise, Vildagliptin - stratum diet/exercise |
Primary outcome
GLP-1 feedback inhibition
Time frame: 0-240 min following meal ingestion
Comparison of the percentage reduction or its reciprocal value (times 100) in total GLP-1 (secretion, incremental values above baseline, 0-240 min following meal ingestion) between vildagliptin and sitagliptin treatment relative to placebo treatment.
6 secondary outcomes
Relationship of the GLP-1 feedback inhibition [%]
Time frame: 0-240 min following meal ingestion
Differences in glucagon secretion [pmol/l]
Time frame: 0-240 min following meal ingestion
Differences in insulin secretory responses - Insulin [pmol/l]
Time frame: 0-240 min following meal ingestion
Differences in insulin secretory responses - c-peptide [pmol/l]
Time frame: 0-240 min following meal ingestion
Differences in glucose concentrations [mmol/l]
Time frame: 0-240 min following meal ingestion
Incidence of Treatment-Emergent Adverse Events - Safety and tolerability
Time frame: From date of screening until the end of study date, assessed for up to 4.7 months
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 22 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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.
Michael A. Nauck, Prof. principal investigator
Diabeteszentrum Bad Lauterberg
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 Mixed meal test, Vildagliptin and Sitagliptin in people with Type 2 Diabetes, run by Michael A. Nauck 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 10 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 22 Apr 2016. 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. Some participants in this study may receive a placebo. 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?
GLP-1 feedback inhibition (time frame: 0-240 min following meal ingestion). 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 22 Apr 2016.