## Protocol Section
### Identification Module
**NCT ID:** NCT03845179

**Brief Title:** GA 6: The Blood Glucose-lowering Effect of Glucose-dependent Insulinotropic Polypeptide

**Official Title:** The Blood Glucose-lowering Effect of Glucose-dependent Insulinotropic Polypeptide

#### Organization Study ID Info
**ID:** H-18040916
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Gentofte, Copenhagen
### Status Module
#### Completion Date
**Date:** 2020-02-28

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-03-16

**Type:** ACTUAL

**Last Update Submit Date:** 2021-03-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-02-28

**Type:** ACTUAL

#### Start Date
**Date:** 2019-05-29

**Type:** ACTUAL

**Status Verified Date:** 2021-03

#### Study First Post Date
**Date:** 2019-02-19
**Type:** ACTUAL
**Study First Submit Date:** 2019-02-11
**Study First Submit QC Date:** 2019-02-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Gentofte, Copenhagen

#### Responsible Party

**Investigator Affiliation:** University Hospital, Gentofte, Copenhagen

**Investigator Full Name:** Signe Stensen

**Investigator Title:** MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study will investigate if the effect of DPP-4 inhibitors is mediated in part by Glucose-dependent insulinotropic polypeptide.

**Detailed Description:** A randomized, placebo controlled study. Using a GIP receptor antagonist, we will investigate the glucose lowering effect of GIP during treatment with DPP-4 inhibitors.

### Conditions Module

**Conditions:**

- Type2 Diabetes

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** Randomized, placebo-controlled, cross-over.

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** Double blinded study. Both participants and investigators are blinded to interventions.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 12

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Placebo tablet for placebo treatment period. Following treatment: 2 separate interventions/study days (placebo infusion and GIP receptor antagonist)

**Intervention Names:**

- Other: Placebo

- Other: GIP receptor antagonist

- Other: Placebo tablet

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** DPP-4 inhibitor treatment for active treatment period. Following treatment: 2 separate interventions/study days (placebo infusion and GIP receptor antagonist)

**Intervention Names:**

- Other: Placebo

- Other: GIP receptor antagonist

- Drug: DPP-4 inhibitor

**Label:** DPP-4 inhibitor

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- DPP-4 inhibitor

- Placebo

**Description:** Saline infusion

**Name:** Placebo

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- DPP-4 inhibitor

- Placebo

**Description:** Used for infusion on study days

**Name:** GIP receptor antagonist

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- DPP-4 inhibitor

**Description:** Oral administration of DPP-4 inhibitor in active treatment period

**Name:** DPP-4 inhibitor

**Other Names:**

- Sitagliptin

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Placebo

**Description:** Oral administration of placebo tablet in placebo treatment period

**Name:** Placebo tablet

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** Measures from ultrasound sonography

**Measure:** Gallbladder volume

**Time Frame:** 5 hours

**Description:** Repeated measures

**Measure:** Systolic and diastolic blood pressure

**Time Frame:** 5 hours

**Description:** Repeated measures

**Measure:** heart rate

**Time Frame:** 5 hours

#### Primary Outcomes

**Description:** Concentrations of C-peptide during GIP receptor antagonism compared to placebo

**Measure:** C-peptide

**Time Frame:** 5 hours

#### Secondary Outcomes

**Description:** Concentrations of plasma glucose during GIP receptor antagonism compared to placebo

**Measure:** Plasma glucose

**Time Frame:** 5 hours

**Description:** Concentrations of insulin during GIP receptor antagonism compared to placebo

**Measure:** Insulin

**Time Frame:** 5 hours

**Description:** Concentrations of total and intact GIP during GIP receptor antagonism compared to placebo

**Measure:** Total and intact GIP

**Time Frame:** 5 hours

**Description:** Concentrations of total and intact GLP-1 during GIP receptor antagonism compared to placebo

**Measure:** Total and intact GLP-1

**Time Frame:** 5 hours

**Description:** Concentrations of glucagon during GIP receptor antagonism compared to placebo

**Measure:** Glucagon

**Time Frame:** 5 hours

**Description:** Concentrations of CTX during GIP receptor antagonism compared to placebo

**Measure:** CTX

**Time Frame:** 5 hours

**Description:** Concentrations of lipids during GIP receptor antagonism compared to placebo

**Measure:** Lipids

**Time Frame:** 5 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* type 2 diabetes, treatment: lifestyle changes or metformin
* HbA1c \< 75 mmol/mol

Exclusion Criteria:

* diagnosed liver disease
* eGFR \< 60 ml/min/1,73m2
* NYHA III or IV
* anemia.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Copenhagen

**Country:** Denmark

**Facility:** Center for Clinical Metabolic Research

**State:** Hellerup

**Zip:** 2900

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Stensen S, Gasbjerg LS, Rosenkilde MM, Vilsboll T, Holst JJ, Hartmann B, Christensen MB, Knop FK. Endogenous Glucose-Dependent Insulinotropic Polypeptide Contributes to Sitagliptin-Mediated Improvement in beta-Cell Function in Patients With Type 2 Diabetes. Diabetes. 2022 Oct 1;71(10):2209-2221. doi: 10.2337/db22-0059.

**PMID:** 35796651

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000054795

- Term: Incretins

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000011480

- Term: Protease Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M27957

- Name: Dipeptidyl-Peptidase IV Inhibitors

- Relevance: HIGH

- As Found: Artery Bypass Graft

- ID: M335

- Name: Sitagliptin Phosphate

- Relevance: HIGH

- As Found: Anesthetic

- ID: M8866

- Name: Gastric Inhibitory Polypeptide

- Relevance: LOW

- As Found: Unknown

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M27905

- Name: Incretins

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M19609

- Name: HIV Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M14343

- Name: Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068900

- Term: Sitagliptin Phosphate

- ID: D000054873

- Term: Dipeptidyl-Peptidase IV Inhibitors

### Misc Info Module

- Version Holder: 2024-05-24
