## Protocol Section
### Identification Module
**NCT ID:** NCT00652379

**Brief Title:** Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients

**Official Title:** Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients: Impact on Insulin Sensitivity, Glucose Tolerance, and Pharmacoeconomics

#### Organization Study ID Info
**ID:** GH-2007-228
#### Organization
**Class:** OTHER
**Full Name:** University of Aarhus
#### Secondary ID Infos
**ID:** 2007-005244-25
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2011-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-01-26

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-01-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-11

**Type:** ACTUAL

#### Start Date
**Date:** 2008-06

**Status Verified Date:** 2012-01

#### Study First Post Date
**Date:** 2008-04-03
**Type:** ESTIMATED
**Study First Submit Date:** 2008-03-26
**Study First Submit QC Date:** 2008-03-31
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Aarhus University Hospital Skejby

**Class:** OTHER

**Name:** Aarhus University Hospital

**Class:** OTHER

**Name:** The Research Council for Health and Disease, Denmark

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Aarhus

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to investigate if co-treatment of acromegalic patients, who beforehand are considered well-controlled on SA monotherapy, with pegvisomant and SA will improve insulin sensitivity and glucose tolerance, and if these effects of co-treatment can be obtained at a neutral cost as compared to SA mono therapy.

Second to investigate body composition, substrate metabolism, symptoms, intrahepatic and intramyocellular fat.

### Conditions Module

**Conditions:**

- Acromegaly

- Insulin Resistance

- Impaired Glucose Tolerance

**Keywords:**

- Acromegaly

- Insulin sensitivity

- Glucose tolerance

- Body composition

- Growth Hormone

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 18

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose

**Intervention Names:**

- Drug: Pegvisomant

- Drug: Somatostatin analog (lanreotide or octreotide)

**Label:** 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Somatostatin analog, unaltered dosage

**Intervention Names:**

- Drug: Somatostatin analog (lanreotide or octreotide)

**Label:** 2

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** Pegvisomant s.c 15-30 mg 2 times a week

**Name:** Pegvisomant

**Other Names:**

- Somavert

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 1

- 2

**Description:** Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog

**Name:** Somatostatin analog (lanreotide or octreotide)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Insulin sensitivity

**Time Frame:** 0 and after 24 weeks

#### Secondary Outcomes

**Measure:** Glucose tolerance

**Time Frame:** 0 and after 24 weeks

**Measure:** Symptoms, QoL questionaire

**Time Frame:** 0, 12 and 24 weeks

**Measure:** Intrahepatic and intramyocellular fat

**Time Frame:** 0 and 24 weeks

**Measure:** Substrate metabolism

**Time Frame:** 0 and 24 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age \> 18
* Diagnosed with acromegaly
* Safe anticonceptive for fertile women
* Well controlled on somatostatin analog (a serum IGF-I within normal range a nadir GH \< 0.5 µg/l.)

Exclusion Criteria:

* Pregnancy
* Liver disease
* Diabetes mellitus type I
* Magnetic or electronic implants

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Aarhus C

**Country:** Denmark

**Facility:** Department of Endocrinology, Aarhus University Hospital

**State:** Aarhus

**Zip:** 8000

#### Overall Officials

**Official 1:**

**Affiliation:** Aarhus University Hospital

**Name:** Jens Otto L. Jørgensen, MD Professor

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006946

- Term: Hyperinsulinism

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000001849

- Term: Bone Diseases, Endocrine

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000006964

- Term: Hyperpituitarism

- ID: D000010900

- Term: Pituitary Diseases

- ID: D000007027

- Term: Hypothalamic Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000006943

- Term: Hyperglycemia

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10370

- Name: Insulin Resistance

- Relevance: HIGH

- As Found: Insulin Resistance

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M20295

- Name: Glucose Intolerance

- Relevance: HIGH

- As Found: Impaired Glucose Tolerance

- ID: M3531

- Name: Acromegaly

- Relevance: HIGH

- As Found: Acromegaly

- ID: M9997

- Name: Hyperinsulinism

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5128

- Name: Bone Diseases, Endocrine

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13791

- Name: Pituitary Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10077

- Name: Hypothalamic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9994

- Name: Hyperglycemia

- Relevance: LOW

- As Found: Unknown

- ID: T139

- Name: Acromegaly

- Relevance: HIGH

- As Found: Acromegaly

### Condition Browse Module - Meshes

- ID: D000000172

- Term: Acromegaly

- ID: D000007333

- Term: Insulin Resistance

- ID: D000018149

- Term: Glucose Intolerance

### Intervention Browse Module - Ancestors

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M15806

- Name: Somatostatin

- Relevance: HIGH

- As Found: Consequences of

- ID: M17982

- Name: Octreotide

- Relevance: HIGH

- As Found: Neuropathy

- ID: M146123

- Name: Lanreotide

- Relevance: HIGH

- As Found: Search

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000015282

- Term: Octreotide

- ID: C000060347

- Term: Lanreotide

- ID: D000013004

- Term: Somatostatin

### Misc Info Module

- Version Holder: 2024-05-24
