Type 2 DiabetesNCT02792400

The Role of Glucagon in the Effects of Dipeptidyl Peptidase-4 Inhibitors and Sodium-glucose Co-transporter-2 Inhibitors

A study testing LY2403021, Standardised liquid meal and Linagliptin in people with Type 2 Diabetes, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.

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 30 to 75 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: LY2403021, Standardised liquid meal and Linagliptin
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteDenmark
Study dates: May 2016to Jul 2018
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 30 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Caucasians above 30 years of age with diet or metformin treated type 2 diabetes for at least 3 months (diagnosed according to the criteria of the World Health Organization)
Normal haemoglobin
Informed consent

Who cannot join

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
Pregnancy and/or breastfeeding

Show all 10Show fewer

Family history of pancreatic islet tumours
Age above 75 years
Treatment with loop-diuretics (applies only to arms with empagliflozin or empagliflozin placebo)
Chronic heart failure

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Center for Diabetes Research, Gentofte Hospital, Copenhagen University
Hellerup, DK-2900

Other trials in Denmark

About this study

In normal physiology, glucagon from pancreatic alpha cells plays an important role in maintaining glucose homeostasis via its regulatory effect on hepatic glucose production. Patients with type 2 diabetes exhibit elevated plasma glucagon levels in the fasting state, and in response to ingestion of glucose or a mixed meal.glucagon, glucagon concentrations fail to decrease appropriately and may even increase. This diabetic hyperglucagonaemia may therefore contribute importantly to the hyperglycaemia of the patients.

Several glucose-lowering treatment modalities have been shown to affect glucagon levels in patients with type 2 diabetes, but the role of glucagon in the glucose-lowering effects of these treatment modalities has been difficult to discern. By using a glucagon receptor antagonist (GRA) the investigators will exploit glucagon receptor antagonism to delineate the role of glucagon during treatment with sodium-glucose co-transporter 2 (SGLT2) inhibitors and dipeptidyl peptidase 4 (DPP-4) inhibitors, which have been shown to increase and decrease plasma glucagon levels, respectively.

Conditions: Type 2 Diabetes
Being tested: LY2403021, LY2403021 placebo, Standardised liquid meal, Linagliptin, Linagliptin 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.

LY2403021Drug
Glucagon receptor antagonist
LY2403021 placeboDrug
Standardised liquid mealProcedure or surgery
LinagliptinDrug
Also called Trajenta
DPP-4-inhibitor
Linagliptin placeboDrug
EmpagliflozinDrug
Also called Jardiance
SGLT2-inhibitor
Empagliflozin placeboDrug

Study groups in NCT02792400
Study group	Role	What they receive
A1: GRA-placebo + MEAL + DPP4-placebo	Placebo comparator	LY2409021 placebo + 4 hour standardised liquid mixed-meal test + linagliptin placebo Receives: Drug: LY2403021 placebo; Procedure: Standardised liquid meal; Drug: Linagliptin placebo
A2: GRA-active + MEAL + DPP4-placebo	Placebo comparator	300 mg LY2409021 + 4 hour standardised liquid mixed-meal test + linagliptin placebo Receives: Drug: LY2403021; Procedure: Standardised liquid meal; Drug: Linagliptin placebo
A3: GRA-placebo + MEAL + DPP4-active	Active comparator	LY2409021 placebo + 4 hour standardised liquid mixed-meal test + 5 mg linagliptin (Trajenta) Receives: Drug: LY2403021 placebo; Procedure: Standardised liquid meal; Drug: Linagliptin
A4: GRA-active + MEAL + DPP4-active	Active comparator	300 mg LY2409021 + 4 hour standardised liquid mixed-meal test + 5 mg linagliptin (Trajenta) Receives: Drug: LY2403021; Procedure: Standardised liquid meal; Drug: Linagliptin
B1: GRA-placebo + MEAL + SGLT2-placebo	Placebo comparator	LY2409021 placebo + 4 hour standardised liquid mixed-meal test + empagliflozin placebo Receives: Drug: LY2403021 placebo; Procedure: Standardised liquid meal; Drug: Empagliflozin placebo
B2: GRA-active + MEAL + SGLT2-placebo	Placebo comparator	300 mg LY2409021 + 4 hour standardised liquid mixed-meal test + empagliflozin placebo Receives: Drug: LY2403021; Procedure: Standardised liquid meal; Drug: Empagliflozin placebo
B3: GRA-placebo + MEAL + SGLT2-active	Active comparator	LY2409021 placebo + 4 hour standardised liquid mixed-meal test + 25 mg empagliflozin (Jardiance) Receives: Drug: LY2403021 placebo; Procedure: Standardised liquid meal; Drug: Empagliflozin
B4: GRA-active + MEAL + SGLT2-active	Active comparator	300 mg LY2409021 + 4 hour standardised liquid mixed-meal test + 25 mg empagliflozin (Jardiance) Receives: Drug: LY2403021; Procedure: Standardised liquid meal; Drug: Empagliflozin

What is being measured

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

Difference in postprandial glucose excursions (linagliptin)
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 linagliptin (A1, A2, A3, A4)
Difference in postprandial glucose excursions
Difference in postprandial glucose excursions (measured as incremental (baseline substracted) area under the curve
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 empagliflozin (B1, B2, B3, B4)

Secondary outcomes (11)

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.
Measured: : 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 standardised liquid meal test, food intake will be examined with an ad libitum meal. The weight of the food will be measured in grams and calculated to the energy intake in kcal/kJ
Measured: At time 240 to 270, the participants will eat an ad libitum meal.
Changes in blood pressure (mmHg)
Measured: Measured at time 0 and time 210 minutes.
Changes in pulse rate (beat per minute)
Measured: Measured at time 0 and at time 210 minutes.
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
Plasma Fibroblast growth factor-21
Measured: -30,-15, 0, 10, 20, 30, 50, 70, 90, 105, 120, 150, 240 minutes
Resting energy expenditure
Resting energy expenditure evaluated by 10 minutes of indirect calorimetry.
Measured: -60 to -50 and 35 to 45

Timeline

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

May 2016Jul 2018

First posted7 Jun 2016 (estimated)
Study startMay 2016
Primary completionAug 2016
Study completionJul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02792400
Sponsor's protocol ID: H-15018701
Status last verified: Nov 2017
First submitted: 1 Jun 2016
Last updated: 8 Apr 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Haedersdal S, Lund A, Nielsen-Hannerup E, Maagensen H, van Hall G, Holst JJ, Knop FK, Vilsboll T. The Role of Glucagon in the Acute Therapeutic Effects of SGLT2 Inhibition. Diabetes. 2020 Dec;69(12):2619-2629. doi: 10.2337/db20-0369. Epub 2020 Oct 1.
PubMed 33004472
Cox AR, Chernis N, Bader DA, Saha PK, Masschelin PM, Felix JB, Sharp R, Lian Z, Putluri V, Rajapakshe K, Kim KH, Villareal DT, Armamento-Villareal R, Wu H, Coarfa C, Putluri N, Hartig SM. STAT1 Dissociates Adipose Tissue Inflammation From Insulin Sensitivity in Obesity. Diabetes. 2020 Dec;69(12):2630-2641. doi: 10.2337/db20-0384. Epub 2020 Sep 29.
PubMed 32994273

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?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of Glucagon in the Effects of Dipeptidyl Peptidase-4 Inhibitors and Sodium-glucose Co-transporter-2 Inhibitors
ClinicalTrials.gov ID: NCT02792400
Acronym / sponsor ID: H-15018701
Conditions: Type 2 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University Hospital, Gentofte, CopenhagenUniversity, hospital or other
Collaborators: Eli Lilly and Company
Study start: May 2016
Primary completion: Aug 2016 (actual)
Study completion: Jul 2018 (actual)
First posted: 7 Jun 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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
A1: GRA-placebo + MEAL + DPP4-placebo	Placebo comparator	Drug: LY2403021 placebo, Procedure: Standardised liquid meal, Drug: Linagliptin placeboLY2409021 placebo + 4 hour standardised liquid mixed-meal test + linagliptin placebo
A2: GRA-active + MEAL + DPP4-placebo	Placebo comparator	Drug: LY2403021, Procedure: Standardised liquid meal, Drug: Linagliptin placebo300 mg LY2409021 + 4 hour standardised liquid mixed-meal test + linagliptin placebo
A3: GRA-placebo + MEAL + DPP4-active	Active comparator	Drug: LY2403021 placebo, Procedure: Standardised liquid meal, Drug: LinagliptinLY2409021 placebo + 4 hour standardised liquid mixed-meal test + 5 mg linagliptin (Trajenta)
A4: GRA-active + MEAL + DPP4-active	Active comparator	Drug: LY2403021, Procedure: Standardised liquid meal, Drug: Linagliptin300 mg LY2409021 + 4 hour standardised liquid mixed-meal test + 5 mg linagliptin (Trajenta)
B1: GRA-placebo + MEAL + SGLT2-placebo	Placebo comparator	Drug: LY2403021 placebo, Procedure: Standardised liquid meal, Drug: Empagliflozin placeboLY2409021 placebo + 4 hour standardised liquid mixed-meal test + empagliflozin placebo
B2: GRA-active + MEAL + SGLT2-placebo	Placebo comparator	Drug: LY2403021, Procedure: Standardised liquid meal, Drug: Empagliflozin placebo300 mg LY2409021 + 4 hour standardised liquid mixed-meal test + empagliflozin placebo
B3: GRA-placebo + MEAL + SGLT2-active	Active comparator	Drug: LY2403021 placebo, Procedure: Standardised liquid meal, Drug: EmpagliflozinLY2409021 placebo + 4 hour standardised liquid mixed-meal test + 25 mg empagliflozin (Jardiance)
B4: GRA-active + MEAL + SGLT2-active	Active comparator	Drug: LY2403021, Procedure: Standardised liquid meal, Drug: Empagliflozin300 mg LY2409021 + 4 hour standardised liquid mixed-meal test + 25 mg empagliflozin (Jardiance)

Who may qualify

Ages: 30 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Caucasians above 30 years of age with diet or metformin treated type 2 diabetes for at least 3 months (diagnosed according to the criteria of the World Health Organization)
Normal haemoglobin
Informed consent

Key exclusion criteria (10 listed)

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

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
LY2403021Glucagon receptor antagonist	Drug	A2: GRA-active + MEAL + DPP4-placebo, A4: GRA-active + MEAL + DPP4-active, B2: GRA-active + MEAL + SGLT2-placebo, B4: GRA-active + MEAL + SGLT2-active
LY2403021 placebo	Drug	A1: GRA-placebo + MEAL + DPP4-placebo, A3: GRA-placebo + MEAL + DPP4-active, B1: GRA-placebo + MEAL + SGLT2-placebo, B3: GRA-placebo + MEAL + SGLT2-active
Standardised liquid meal	Procedure or surgery	A1: GRA-placebo + MEAL + DPP4-placebo, A2: GRA-active + MEAL + DPP4-placebo, A3: GRA-placebo + MEAL + DPP4-active, A4: GRA-active + MEAL + DPP4-active, B1: GRA-placebo + MEAL + SGLT2-placebo, B2: GRA-active + MEAL + SGLT2-placebo, B3: GRA-placebo + MEAL + SGLT2-active, B4: GRA-active + MEAL + SGLT2-active
LinagliptinAlso: TrajentaDPP-4-inhibitor	Drug	A3: GRA-placebo + MEAL + DPP4-active, A4: GRA-active + MEAL + DPP4-active
Linagliptin placebo	Drug	A1: GRA-placebo + MEAL + DPP4-placebo, A2: GRA-active + MEAL + DPP4-placebo
EmpagliflozinAlso: JardianceSGLT2-inhibitor	Drug	B3: GRA-placebo + MEAL + SGLT2-active, B4: GRA-active + MEAL + SGLT2-active
Empagliflozin placebo	Drug	B1: GRA-placebo + MEAL + SGLT2-placebo, B2: GRA-active + MEAL + SGLT2-placebo

Primary outcome

Difference in postprandial glucose excursions (linagliptin)
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 linagliptin (A1, A2, A3, A4)
Difference in postprandial glucose excursions (measured as incremental (baseline substracted) area under the curve (AUC) values).
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 empagliflozin (B1, B2, B3, B4)
Difference in postprandial glucose excursions (measured as incremental (baseline substracted) area under the curve

11 secondary outcomes

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: : 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.
Changes in blood pressure (mmHg)
Time frame: Measured at time 0 and time 210 minutes.
Changes in pulse rate (beat per minute)
Time frame: Measured at time 0 and at time 210 minutes.
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
Plasma Fibroblast growth factor-21
Time frame: -30,-15, 0, 10, 20, 30, 50, 70, 90, 105, 120, 150, 240 minutes
Resting energy expenditure
Time frame: -60 to -50 and 35 to 45

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 8 Apr 2020.
Derived from this study: PubMed 33004472Haedersdal S, Lund A, Nielsen-Hannerup E, Maagensen H, van Hall G, Holst JJ, Knop FK, Vilsboll T. The Role of Glucagon in the Acute Therapeutic Effects of SGLT2 Inhibition. Diabetes. 2020 Dec;69(12):2619-2629. doi: 10.2337/db20-0369. Epub 2020 Oct 1.
Derived from this study: PubMed 32994273Cox AR, Chernis N, Bader DA, Saha PK, Masschelin PM, Felix JB, Sharp R, Lian Z, Putluri V, Rajapakshe K, Kim KH, Villareal DT, Armamento-Villareal R, Wu H, Coarfa C, Putluri N, Hartig SM. STAT1 Dissociates Adipose Tissue Inflammation From Insulin Sensitivity in Obesity. Diabetes. 2020 Dec;69(12):2630-2641. doi: 10.2337/db20-0384. Epub 2020 Sep 29.
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 LY2403021, Standardised liquid meal and Linagliptin 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 3 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 8 Apr 2020. 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?

Difference in postprandial glucose excursions (linagliptin) (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 linagliptin (A1, A2, A3, A4)). 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?

On the ClinicalTrials.gov record for NCT02792400, which also lists 2 linked publications.

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 8 Apr 2020.