Type 2 DiabetesNCT02669524
Dissection of the Gastrointestinal-mediated Glucose Disposal and Incretin Defect in Patients With Type 2 Diabetes
A study testing LY2409021, OGTT and IIGI in people with Type 2 Diabetes, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
In patients with type 2 diabetes, the incretin effect is markedly reduced contributing to the relative insulin deficiency that characterizes these patients. This defect is believed to be due to a decreased effect of GLP-1 and an almost ceased effect of GIP. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- LY2409021, OGTT and IIGI
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to Aug 2016
- Phase
- Interventional
- 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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes
- Caucasians above 35 years of age with diet or metformin treated type 2 diabetes for at least 3 month (diagnosed according to the criteria of the World Health Organization (WHO)
- Normal haemoglobin
- Informed consent
- Healthy subjects
- Normal fasting plasma glucose (FPG) <6.1 mmol/l and HbA1c <42 mmol/mol (6.0%)
Show all 9Show fewer
- Normal haemoglobin
- Age above 35 years
- Informed consent
Who cannot join
- Patients with type 2 diabetes
- Inflammatory bowel disease
- Intestinal resections
- Nephropathy (serum creatinine above normal range and/or albuminuria)
- Liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2×normal values)
- Treatment with medicine that cannot be paused for 12 hours
Show all 17Show fewer
- Pregnancy and/or breastfeeding
- Family history of pancreatic islet tumours
- Age above 80 years
- Healthy subjects
- Diabetes or prediabetes with reduced glucose tolerance: FPG >6.0 mmol/l and/or HbA1c >42 mmol/mol
- First degree relatives with type 2 diabetes
- Inflammatory bowel disease
- Intestinal resections
- Treatment with medicine that cannot be paused for 12 hours
- Pregnancy and/or breastfeeding
- Age above 80 years
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Diabetes Research, Gentofte Hospital, Copenhagen University
Hellerup, DK-2900
About this study
Official title: Dissection of the Gastrointestinal-mediated Glucose Disposal and Incretin Defect in Patients With Type 2 Diabetes - the Role of Glucagon
In patients with type 2 diabetes, the incretin effect is markedly reduced contributing to the relative insulin deficiency that characterizes these patients. This defect is believed to be due to a decreased effect of GLP-1 and an almost ceased effect of GIP. Nevertheless, the impact of the defect on glucose tolerance is not fully understood. The so-called gastrointestinal-mediated glucose disposal (GIGD) is a measure of glucose handling, which includes the incretin effect, but also other factors affecting glucose disposal (e.g. glucagon secretion). Interestingly, patients with type 2 diabetes exhibit elevated plasma glucagon levels in the fasting state, and glucagon concentrations fail to decrease appropriately and may even increase in response to ingestion of glucose and show exaggerated increases after a mixed meal. With the current project the investigators wish to elucidate how this paradoxical glucagon response observed in patients with type 2 diabetes affects the GIGD, the incretin effect and postprandial glucose excursions.
Ten patients with type 2 diabetes and 10 healthy matched control subjects will be enrolled in this randomised, placebo-controlled, double-blinded study. The aim is to examine the effect of a glucagon receptor antagonist (GRA) on gastrointestinal-mediated glucose disposal (GIGD), incretin effect and postprandial glucose excursions in patients with type 2 diabetes and healthy controls. Participants will attend two oral glucose tolerance tests (OGTT), two isoglycaemic iv glucose infusion (IIGI) and two standardised liquid meals.
- Conditions
- Type 2 Diabetes
- Being tested
- LY2409021, LY2409021 placebo, OGTT, IIGI, Standardised liquid meal
- 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.
LY2409021Drug
LY2409021 placeboDrug
OGTTProcedure or surgery
IIGIProcedure or surgery
Standardised liquid mealProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| T2D + OGTT + LY2409021 | Active comparator | Type 2 diabetes patients + 50 oral glucose tolerance test 4 hours + the human antagonist of the glucagon receptor. Receives: Drug: LY2409021; Procedure: OGTT |
| T2D + OGTT + placebo | Placebo comparator | Type 2 diabetes patients + 50 oral glucose tolerance test 4 hours + placebo comparator to the human antagonist of the glucagon receptor. Receives: Drug: LY2409021 placebo; Procedure: OGTT |
| T2D + IIGI + LY2409021 | Active comparator | Type 2 diabetes patients + isoglycaemic iv glucose infusion + the human antagonist of the glucagon receptor. Receives: Drug: LY2409021; Procedure: IIGI |
| T2D + IIGI + placebo | Placebo comparator | Type 2 diabetes patients + isoglycaemic iv glucose infusion + placebo comparator to the human antagonist of the glucagon receptor. Receives: Drug: LY2409021 placebo; Procedure: IIGI |
| T2D + MEAL + LY2409021 | Active comparator | Type 2 diabetes patients + Standardised liquid meal + the human antagonist of the glucagon receptor. Receives: Drug: LY2409021; Procedure: Standardised liquid meal |
| T2D + MEAL + placebo | Placebo comparator | Type 2 diabetes patients + Standardised liquid meal + placebo comparator to the human antagonist of the glucagon receptor. Receives: Drug: LY2409021 placebo; Procedure: Standardised liquid meal |
| CTRL + OGTT + LY2409021 | Active comparator | Healthy controls + 50 oral glucose tolerance test 4 hours + the human antagonist of the glucagon receptor. Receives: Drug: LY2409021; Procedure: OGTT |
| CTRL + OGTT + placebo | Placebo comparator | Healthy controls + 50 oral glucose tolerance test 4 hours + placebo comparator of the human antagonist of the glucagon receptor. Receives: Drug: LY2409021 placebo; Procedure: OGTT |
| CTRL + IIGI + LY2409021 | Active comparator | Healthy controls + isoglycaemic iv glucose infusion + the human antagonist of the glucagon receptor. Receives: Drug: LY2409021; Procedure: IIGI |
| CTRL + IIGI + placebo | Placebo comparator | Healthy controls + isoglycaemic iv glucose infusion + placebo comparator the human antagonist of the glucagon receptor. Receives: Drug: LY2409021 placebo; Procedure: IIGI |
| CTRL + MEAL + LY2409021 | Active comparator | Healthy controls + Standardised liquid meal + the human antagonist of the glucagon receptor. Receives: Drug: LY2409021; Procedure: Standardised liquid meal |
| CTRL + MEAL + placebo | Placebo comparator | Healthy controls + Standardised liquid meal + placebo comparator of the human antagonist of the glucagon receptor. Receives: Drug: LY2409021 placebo; Procedure: Standardised liquid meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in GIGD (%)
GIGD = Gastrointestinal glucose disposal. GIGD (%) = 100% × (glucoseOGTT-glucoseIIGI)/glucoseOGTT.
Measured: Comparison between experimental days with and without the glucagon receptor antagonist . The glucose disposal at time 240 minutes will be used.
Difference in postprandial glucose excursions
Difference in postprandial glucose excursions (measured as incremental (baseline substracted) area under the curve (AUC) values).
Measured: Area under the curve (AUC) time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 105, 120, 150, 180, 210, 240 minutes. Comparison between experimental days with and without the glucagon receptor antagonist.
Secondary outcomes (11)
Incretin effect
The incretin effect (100% × [β-cell secretory response to oral glucose tolerance test - intravenous β-cell secretory response]/β-cell secretory response to oral glucose tolerance test)
Measured: Insulin AUC time frame: 0,10, 20, 30, 50, 60, 70, 90, 105, 120, 150, 240 minutes. Comparison between experimental days with and without the glucagon receptor antagonist
Endogenous glucose production
Glucose rate of appearance will be calculated by the non-steady state equation using double tracer technique.
Measured: Plasma concentration of 6,6^2 H2-glucose and U-13C^6-glucose at times: 0,10, 20, 30, 50, 60, 70, 90, 105, 120, 150, 240 minutes.
Lipolysis
Glycerol disappearance will be calculated by the non-steady state equation using double tracer technique.
Measured: Plasma concentration of 1,1,2,3,3-^2-H5 - glycerol measured at times: 0,10, 20, 30, 50, 60, 70, 90, 105, 120, 150, 240 minutes.
Serum/plasma concentrations of insulin, C-peptide, glucagon, GIP and GLP-1.
Insulin, C-peptide, glucagon, GIP and GLP-1 serum/plasma concentrations will be measured in pM.
Measured: Time frame: 0,10, 20, 30, 50, 60, 70, 90, 105, 120, 150, 240 minutes.
Appetite
Appetite will be evaluated with a visual analogue scale (VAS).
Measured: VAS scales will be handed out at time 0, 30, 60, 90, 120, 150, 180 and 240 minutes.
Energy intake (kcal/kJ)
At the end of the clamp experiment food intake will be examined with an ad libitum meal. The weight of the food will be measured i grams and calculated to the energy intake in kcal/kJ.
Measured: At time 240 to 270, the participants will eat an ad libitum meal. Comparison between experimental days with and without the glucagon receptor antagonist
Changes in blood pressure (mmHg)
Measured: Measured at time 0 and time 210 minutes. Comparison between experimental days with and without the glucagon receptor antagonist
Changes in pulse rate (beat per minute)
Measured: Measured at time 0 and at time 210 minutes. Comparison between experimental days with and without the glucagon receptor antagonist
Differences in gastric emptying
Measurement of p-paracetamol. Measurement of time to peak and incremental area under the curve (iAUC)
Measured: -30,-15, 0, 10, 20, 30, 50, 70, 90, 105, 120, 150, 240 minutes
Free fatty acids
serum values of free fatty acids
Measured: -30,-15, 0, 10, 20, 30, 50, 70, 90, 105, 120, 150, 240 minutes
Fibroblast growth factor-21
plasma values of FGF-21
Measured: -30,-15, 0, 10, 20, 30, 50, 70, 90, 105, 120, 150, 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startOct 2015
- Primary completionAug 2016
- Study completionAug 2016
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Sofie Hædersdal, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669524
- Sponsor's protocol ID
- H-15007312
- Status last verified
- Oct 2016
- First submitted
- 14 Dec 2015
- Last updated
- 25 Oct 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 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissection of the Gastrointestinal-mediated Glucose Disposal and Incretin Defect in Patients With Type 2 Diabetes - the Role of Glucagon
- ClinicalTrials.gov ID
- NCT02669524
- Acronym / sponsor ID
- H-15007312
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Oct 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 1 Feb 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.
In patients with type 2 diabetes, the incretin effect is markedly reduced contributing to the relative insulin deficiency that characterizes these patients. This defect is believed to be due to a decreased effect of GLP-1 and an almost ceased effect of GIP. Nevertheless, the impact of the defect on glucose tolerance is not fully understood. The so-called gastrointestinal-mediated glucose disposal (GIGD) is a measure of glucose handling, which includes the incretin effect, but also other factors affecting glucose disposal (e.g. glucagon secretion). Interestingly, patients with type 2 diabetes exhibit elevated plasma glucagon levels in the fasting state, and glucagon concentrations fail to decrease appropriately and may even increase in response to ingestion of glucose and show exaggerated increases after a mixed meal. With the current project the investigators wish to elucidate how this paradoxical glucagon response observed in patients with type 2 diabetes affects the GIGD, the incretin effect and postprandial glucose excursions.
Ten patients with type 2 diabetes and 10 healthy matched control subjects will be enrolled in this randomised, placebo-controlled, double-blinded study. The aim is to examine the effect of a glucagon receptor antagonist (GRA) on gastrointestinal-mediated glucose disposal (GIGD), incretin effect and postprandial glucose excursions in patients with type 2 diabetes and healthy controls. Participants will attend two oral glucose tolerance tests (OGTT), two isoglycaemic iv glucose infusion (IIGI) and two standardised liquid meals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| T2D + OGTT + LY2409021 | Active comparator | Drug: LY2409021, Procedure: OGTTType 2 diabetes patients + 50 oral glucose tolerance test 4 hours + the human antagonist of the glucagon receptor. |
| T2D + OGTT + placebo | Placebo comparator | Drug: LY2409021 placebo, Procedure: OGTTType 2 diabetes patients + 50 oral glucose tolerance test 4 hours + placebo comparator to the human antagonist of the glucagon receptor. |
| T2D + IIGI + LY2409021 | Active comparator | Drug: LY2409021, Procedure: IIGIType 2 diabetes patients + isoglycaemic iv glucose infusion + the human antagonist of the glucagon receptor. |
| T2D + IIGI + placebo | Placebo comparator | Drug: LY2409021 placebo, Procedure: IIGIType 2 diabetes patients + isoglycaemic iv glucose infusion + placebo comparator to the human antagonist of the glucagon receptor. |
| T2D + MEAL + LY2409021 | Active comparator | Drug: LY2409021, Procedure: Standardised liquid mealType 2 diabetes patients + Standardised liquid meal + the human antagonist of the glucagon receptor. |
| T2D + MEAL + placebo | Placebo comparator | Drug: LY2409021 placebo, Procedure: Standardised liquid mealType 2 diabetes patients + Standardised liquid meal + placebo comparator to the human antagonist of the glucagon receptor. |
| CTRL + OGTT + LY2409021 | Active comparator | Drug: LY2409021, Procedure: OGTTHealthy controls + 50 oral glucose tolerance test 4 hours + the human antagonist of the glucagon receptor. |
| CTRL + OGTT + placebo | Placebo comparator | Drug: LY2409021 placebo, Procedure: OGTTHealthy controls + 50 oral glucose tolerance test 4 hours + placebo comparator of the human antagonist of the glucagon receptor. |
| CTRL + IIGI + LY2409021 | Active comparator | Drug: LY2409021, Procedure: IIGIHealthy controls + isoglycaemic iv glucose infusion + the human antagonist of the glucagon receptor. |
| CTRL + IIGI + placebo | Placebo comparator | Drug: LY2409021 placebo, Procedure: IIGIHealthy controls + isoglycaemic iv glucose infusion + placebo comparator the human antagonist of the glucagon receptor. |
| CTRL + MEAL + LY2409021 | Active comparator | Drug: LY2409021, Procedure: Standardised liquid mealHealthy controls + Standardised liquid meal + the human antagonist of the glucagon receptor. |
| CTRL + MEAL + placebo | Placebo comparator | Drug: LY2409021 placebo, Procedure: Standardised liquid mealHealthy controls + Standardised liquid meal + placebo comparator of the human antagonist of the glucagon receptor. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with type 2 diabetes
- Caucasians above 35 years of age with diet or metformin treated type 2 diabetes for at least 3 month (diagnosed according to the criteria of the World Health Organization (WHO)
- Normal haemoglobin
- Informed consent
- Healthy subjects
Key exclusion criteria (17 listed)
- Patients with type 2 diabetes
- Inflammatory bowel disease
- Intestinal resections
- Nephropathy (serum creatinine above normal range and/or albuminuria)
- Liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2×normal values)
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 |
|---|---|---|
| LY2409021 | Drug | CTRL + IIGI + LY2409021, CTRL + MEAL + LY2409021, CTRL + OGTT + LY2409021, T2D + IIGI + LY2409021, T2D + MEAL + LY2409021, T2D + OGTT + LY2409021 |
| LY2409021 placebo | Drug | CTRL + IIGI + placebo, CTRL + MEAL + placebo, CTRL + OGTT + placebo, T2D + IIGI + placebo, T2D + MEAL + placebo, T2D + OGTT + placebo |
| OGTT | Procedure or surgery | CTRL + OGTT + LY2409021, CTRL + OGTT + placebo, T2D + OGTT + LY2409021, T2D + OGTT + placebo |
| IIGI | Procedure or surgery | CTRL + IIGI + LY2409021, CTRL + IIGI + placebo, T2D + IIGI + LY2409021, T2D + IIGI + placebo |
| Standardised liquid meal | Procedure or surgery | CTRL + MEAL + LY2409021, CTRL + MEAL + placebo, T2D + MEAL + LY2409021, T2D + MEAL + placebo |
Primary outcome
Differences in GIGD (%)
Time frame: Comparison between experimental days with and without the glucagon receptor antagonist . The glucose disposal at time 240 minutes will be used.
GIGD = Gastrointestinal glucose disposal. GIGD (%) = 100% × (glucoseOGTT-glucoseIIGI)/glucoseOGTT.
Difference in postprandial glucose excursions
Time frame: Area under the curve (AUC) time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 105, 120, 150, 180, 210, 240 minutes. Comparison between experimental days with and without the glucagon receptor antagonist.
Difference in postprandial glucose excursions (measured as incremental (baseline substracted) area under the curve (AUC) values).
11 secondary outcomes
Incretin effect
Time frame: Insulin AUC time frame: 0,10, 20, 30, 50, 60, 70, 90, 105, 120, 150, 240 minutes. Comparison between experimental days with and without the glucagon receptor antagonist
Endogenous glucose production
Time frame: Plasma concentration of 6,6^2 H2-glucose and U-13C^6-glucose at times: 0,10, 20, 30, 50, 60, 70, 90, 105, 120, 150, 240 minutes.
Lipolysis
Time frame: Plasma concentration of 1,1,2,3,3-^2-H5 - glycerol measured at times: 0,10, 20, 30, 50, 60, 70, 90, 105, 120, 150, 240 minutes.
Serum/plasma concentrations of insulin, C-peptide, glucagon, GIP and GLP-1.
Time frame: Time frame: 0,10, 20, 30, 50, 60, 70, 90, 105, 120, 150, 240 minutes.
Appetite
Time frame: VAS scales will be handed out at time 0, 30, 60, 90, 120, 150, 180 and 240 minutes.
Energy intake (kcal/kJ)
Time frame: At time 240 to 270, the participants will eat an ad libitum meal. Comparison between experimental days with and without the glucagon receptor antagonist
Changes in blood pressure (mmHg)
Time frame: Measured at time 0 and time 210 minutes. Comparison between experimental days with and without the glucagon receptor antagonist
Changes in pulse rate (beat per minute)
Time frame: Measured at time 0 and at time 210 minutes. Comparison between experimental days with and without the glucagon receptor antagonist
Differences in gastric emptying
Time frame: -30,-15, 0, 10, 20, 30, 50, 70, 90, 105, 120, 150, 240 minutes
Free fatty acids
Time frame: -30,-15, 0, 10, 20, 30, 50, 70, 90, 105, 120, 150, 240 minutes
Fibroblast growth factor-21
Time frame: -30,-15, 0, 10, 20, 30, 50, 70, 90, 105, 120, 150, 240 minutes
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 25 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LY2409021, OGTT and IIGI in people with Type 2 Diabetes, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
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 9 inclusion and 17 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 25 Oct 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 Denmark. 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.
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?
Differences in GIGD (%) (time frame: Comparison between experimental days with and without the glucagon receptor antagonist . The glucose disposal at time 240 minutes will be used.). The study lists 2 primary outcomes in all. 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 25 Oct 2016.