12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis

Purpose

To compare the efficacy of relamorelin with placebo in participants with Diabetic Gastroparesis with respect to a composite of the following core signs and symptoms of:  *Nausea *Abdominal pain *Postprandial fullness *Bloating

Criteria

Age 18 years or older at screening

T1 Diabetes Mellitus or T2 Diabetes Mellitus of at least 5 years’ duration, with controlled and stable blood glucose levels (ie, no episodes of diabetic ketoacidosis, Hyperosmolar Hyperglycemic Nonketotic Diabetic Syndrome, or severe hypoglycemia within the 6 months preceding screening.

HbA1c ≤ 11.0% at screening (Visit 1) in participants being treated with oral and/or parenteral medications for T1DM or T2DM with the goal of achieving controlled and stable glucose levels

A 3-month history prior to screening (Visit 1) of symptoms on an ongoing basis that are suggestive of GP (eg, nausea, abdominal pain, post-prandial fullness, bloating, vomiting, and early satiety)

Documentation of absence of an obstructing lesion on upper GI series with contrast or upper endoscopy, performed at some time before the Run-in period (Visit 2), but after the appearance of symptoms that led to the diagnosis of DG

At least 2 vomiting episodes during the 2 weeks prior to screening (Visit 1), as ascertained by participant history.

Compliance with administration of SC twice daily injections, as evidenced by entries made by the participant using the electronic, hand-held device on at least 10 of 14 days during the placebo Run-in Period

At least one vomiting episode at any time during the placebo Run-in Period, as recorded in the DGSSD, using the electronic hand-held device

You Cannot:

Symptomatic Irritable Bowel Syndrome at Screening (Visit 1)

Small intestinal bacterial overgrowth (SIBO) at Screening (Visit 1)

Participants who are actively experiencing anorexia nervosa, binge-eating, bulimia, or other eating disorder at the time of Screening (Visit 1) are excluded regardless of when diagnosis was established.

History of intestinal malabsorption (including celiac disease even if well-controlled on a gluten-free diet) or pancreatic exocrine insufficiency; also, history of non-celiac gluten sensitivity

History of belching disorders, other nausea and vomiting disorders (eg, chronic nausea and vomiting syndrome, cyclic vomiting syndrome, cannabinoid hyperemesis syndrome), or rumination syndrome

History of COPD or other causes of pulmonary dysfunction that have resulted in CO2 retention

Gastric or duodenal ulcer within 3 months of Screening (Visit 1)

Hx of malignancy in the 3 years prior to V1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer

Currently receiving parenteral feeding or presence of a NG or other enteral tube for feeding or decompression ·         Positive results on the urine drug screen at Screening ·         Currently taking opioids, or expecting to use opioids during the course of the clinical study

History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure (a history of diagnostic endoscopy is not exclusionary)

Allergic to, or intolerant of egg, wheat, milk, or algae, as these are components of the GEBT study meal

Details

Screening up to 4 weeks

Run-in Period: enter a 2-week Run-in Period, during which you will self-administer placebo twice daily SC. Using an electronic hand-held device, participants will report their symptoms via the Diabetic Gastroparesis Symptom Severity Diary (DGSSD) as well as their overall global impression of status, treatment satisfaction, compliance, and use of rescue medication

12-week Treatment Period: Participants who meet study entry criteria at the end of the Run-in Period, will be randomized 1:1 to blinded treatment with relamorelin 10 μg or placebo, and will continue to use the electronic handheld device for reporting of their symptoms Assuming they meet entry criteria, those who successfully complete this study are eligible, to enter a placebo-controlled, long-term safety and efficacy study (RLM-MD-03) and receive study treatment for an additional 46 wks.

Interested in more information? Contact Us:

IRB: Copernicus
IRB Number:
Trial Type: Drug
Sponsor: Allergan