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A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04

Phase 3
Conditions
Health Condition 1: E106- Type 1 diabetes mellitus with other specified complicationsHealth Condition 2: E116- Type 2 diabetes mellitus with other specified complications
Registration Number
CTRI/2019/03/018134
Lead Sponsor
Allergan
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Other (Terminated)
Sex
Not specified
Target Recruitment
1
Inclusion Criteria

1)Two different groups of participants may enter into the study:

2)Participants must meet all the inclusion criteria at screening (Visit 1) and at the end of the Run-in Period (Visit 3) for randomization into the Treatment Period of RLM-MD-01 (NCT03285308) (including compliance with dosing, entry of diary data into the DGSSD during the lead-in study Run-in Period) during the lead-in study Run-in Period at the end of the lead-in study Run-in Period, are eligible for randomization in Study RLM-MD-04 if:

a) They had no vomiting episodes recorded in the DGSSD and had an average daily DGSSS greater than or equals to 12 at the end of the lead-in study Run-in Period.

OR

b) They had vomiting episodes recorded in the DGSSD but had an average daily DGSSS of greaterthan or equals to 12 and less than 16 at the end of the lead-in study Run-in Period.

In the current study, these rollover participants will enter the study at Visit 1 (Randomization); they will not undergo Screening (Visit -2) or the Run-in Visit (Visit -1) procedures.

Patients who undergo screening and run-in procedures in Study RLM-MD-04 are de novo participants. To be eligible for randomization in the current study, de novo participants must meet all Screening and Run-in Period criteria for Study RLM-MD-04, including:

1.At Screening, be male or female age 18 years and older, with BMI greater than 18.5 kg/m2; T1DM or T2DM with controlled and stable blood glucose levels and HbA1c less than or equals to 11%; symptoms suggestive of DG for at least 3 months (one of which must be nausea), with mechanical obstruction of the GI tract as the cause of symptoms having been ruled out; delayed GE by gastric emptying breath test (GEBT).

2.After Run-in Period: Evidence of compliance during the Run-in Period with the use of the electronic hand-held device for entry of data, with twice daily SC injections of the study treatment, and no treatment with GI promotility agents; a score of greater than or equals to 12 for the average of the daily DGSSS measured during the Run-in Period.

Exclusion Criteria

There are no exclusion criteria specific to this study; participants will be excluded from this study if any of the exclusion criteria apply at screening (Visit 1) and at the end of the Run-in Period (Visit 3) for randomization into the Treatment Period of studies RLM-MD-01 and RLM-MD-02, except as specified in the inclusion criteria

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.% of patients meeting the diabetic gastroparesis(DG) symptom responder criterion in each of the last 6 of the 12 weeks of treatment. Patients will assess severity of DG symptoms daily using an 11 point ordinal scale with 0 (least) and 10 (worst) possible score. Patients will enter the score using an e diary. <br/ ><br>2.% of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment. Vomiting episodes will be patient recorded daily using an e diary. <br/ ><br>Timepoint: <br/ ><br>1.Baseline to week 12 <br/ ><br>2.Baseline to week 12 <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
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