A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04
Study Details
Study Description
Brief Summary
A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Placebo Comparator: Placebo Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. |
Drug: Placebo
Placebo injected subcutaneously twice daily.
|
Experimental: Relamorelin 10 μg Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. |
Drug: Relamorelin
Relamorelin 10 μg injected subcutaneously twice daily.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) [Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 12 of this study]
Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants.
- Change From Baseline to Week 52 in the Weekly Average DGSSS [Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 52 of this study]
Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). The average weekly scores at Week 52 were the average of the DGSSS scores from Week 49 to Week 52. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants.
- Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) [First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks)]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
- Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results [Up to 52 weeks]
Clinical Laboratory tests included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 participant had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
- Number of Participants With Clinically Meaningful Trends for Vital Signs [Up to 52 weeks]
Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.
- Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results [Up to 52 weeks]
A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
- Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HbA1c) [Up to 52 weeks]
- Number of Participants With Anti-relamorelin Antibody Testing Results by Visit [Baseline (Day 1), Day 84, Day 364, and End of Treatment (Up to Day 364)]
A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.
Eligibility Criteria
Criteria
Inclusion Criteria:
Two different groups of participants may enter into the study:
- Rollover Participants
Participants who were not randomization-eligible at the end of the Run-in Period of lead-in studies RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) are eligible to be randomized in the study if all of the following criteria apply:
•In the lead-in studies, participants must have met all screening visit and Run-in Period criteria for randomization into the Treatment Period (including compliance with dosing, entry of diary data into the Diabetic Gastroparesis Symptom Severity Diary (DGSSD)) except that:
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They had zero vomiting episodes and an average daily Diabetic Gastroparesis Symptom Severity Score (DGSSS) of ≥12 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device; OR
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They had vomiting episodes and an average daily DGSSS of ≥12 but <16 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device
- De Novo Participants
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Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) of at least 5 years' duration, with controlled and stable blood glucose levels and hemoglobin A1c (HBA1c) ≤11%
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DG defined as at least a 3-month history prior to Screening of symptoms (one of which must be nausea) on an ongoing basis that are suggestive of gastroparesis (GP) (e.g., nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety)
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Compliance with the entry of data into the hand-held electronic device during the Run-in Period
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Compliance with administration of subcutaneous (SC) twice daily injections during the Run-in Period
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The average of the daily DGSSS from the 2-week, Run-in Period must be ≥12
Exclusion Criteria:
- Both Rollover and De Novo Participants
•Participants with a known allergy or hypersensitivity to the study treatments and their excipients (i.e., mannitol or phenol)
- Rollover Participants
•Participants will be excluded from this study if any of the lead-in study exclusion criteria apply at the Screening Visit and at the end of the Run-in Period for randomization into the Treatment Period of studies RLM-MD-01 and RLM-MD-02, except as specified in the inclusion criteria
- De Novo Participants
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History of anorexia nervosa, binge-eating, bulimia, or other eating disorder within 5 years of the Screening Visit
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History of intestinal malabsorption or pancreatic exocrine insufficiency
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History of belching disorders, other nausea and vomiting disorders
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Gastric or duodenal ulcer within 3 months of Screening
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History of malignancy in the 3 years prior to Screening, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
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Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression
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Use of metoclopramide, domperidone, prucalopride, macrolide antibiotics (e.g., erythromycin, clarithromycin, azithromycin), or other drugs considered to be GI promotility agents for at least 10 days prior to the start of the Run-in Period
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Currently taking opiates, or expecting to use opiates during the course of the clinical study
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Treatment with glucagon-like peptide-1 (GLP-1) agonist for at least 6 weeks prior to the start of the Run-in Period
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History of pyloric injection of botulinum toxin within 6 months of screening
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History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure (a history of diagnostic endoscopy is not exclusionary)
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Randomization in any previous study in which relamorelin was a treatment
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Allergic to, or intolerant of egg, wheat, milk, or algae, as these are components of the gastric emptying breath test (GEBT) study meal
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Pinnacle Research Group | Anniston | Alabama | United States | 36207 |
2 | North Alabama Research Center, LLC | Athens | Alabama | United States | 35611 |
3 | Simon Williamson Clinic | Birmingham | Alabama | United States | 35211 |
4 | Digestive Health Specialist of the South East | Dothan | Alabama | United States | 36305 |
5 | G & L Research, LLC | Foley | Alabama | United States | 36535 |
6 | Avant Research Associates | Huntsville | Alabama | United States | 35801 |
7 | Alabama Medical Group, PC | Mobile | Alabama | United States | 36608 |
8 | Phoenix Clinical LLC. | Phoenix | Arizona | United States | 85014 |
9 | Del Sol Research Management, LLC | Tucson | Arizona | United States | 85710 |
10 | Del Sol Research Management, LLC | Tucson | Arizona | United States | 85712 |
11 | Synexus Clinical Research US, Inc. | Tucson | Arizona | United States | 85741 |
12 | Preferred Research Partners, Inc. | Little Rock | Arkansas | United States | 72211 |
13 | Applied Research Center of Arkansas | Little Rock | Arkansas | United States | 72212 |
14 | Arkansas Gastroenterology | North Little Rock | Arkansas | United States | 72117 |
15 | Unity Health - Searcy Medical Center | Searcy | Arkansas | United States | 72143 |
16 | Hope Clinical Research | Canoga Park | California | United States | 91303 |
17 | GW Research Inc | Chula Vista | California | United States | 91910 |
18 | Kindred Medical Institute for Clinical Trials, LLC | Corona | California | United States | 92879 |
19 | Aurora Care Clinic, LLC | Costa Mesa | California | United States | 92627 |
20 | TriWest Research Associates | El Cajon | California | United States | 92020 |
21 | Diagnamics Inc. | Encinitas | California | United States | 92024 |
22 | VVCRD Research | Garden Grove | California | United States | 92845 |
23 | University of California San Diego | La Jolla | California | United States | 92037 |
24 | Om Research LLC | Lancaster | California | United States | 93534 |
25 | Torrance Clinical Research Institute, Inc. | Lomita | California | United States | 90717 |
26 | Angel City Research Inc. | Los Angeles | California | United States | 90057 |
27 | Stanford Hospital | Palo Alto | California | United States | 94304 |
28 | Optimal Research California | San Diego | California | United States | 92108 |
29 | Medical Associates Research Group, Inc | San Diego | California | United States | 92123 |
30 | Syrentis Clinical Research | Santa Ana | California | United States | 92705 |
31 | Upland Clinical Research | Upland | California | United States | 91786 |
32 | Synexus Clinical Research US, Inc. | Vista | California | United States | 92083 |
33 | New Hope Research Development | Whittier | California | United States | 90603 |
34 | Peak Gastroenterology Associates | Colorado Springs | Colorado | United States | 80907 |
35 | Synexus | Colorado Springs | Colorado | United States | 80909 |
36 | Gastroenterology Associates of Fairfield County, P.C. | Bridgeport | Connecticut | United States | 06606 |
37 | Medical Research Center of Connecticut, LLC | Hamden | Connecticut | United States | 06518 |
38 | Innovative Research of West FL, Inc. | Clearwater | Florida | United States | 33756 |
39 | Clinical Research of West Florida | Clearwater | Florida | United States | 33765 |
40 | ALL Medical Research, LLC | Cooper City | Florida | United States | 33024 |
41 | Top Medical Research | Cutler Bay | Florida | United States | 33189 |
42 | Palmetto Research, LLC | Hialeah | Florida | United States | 33016 |
43 | Vida Clinical Trials | Homestead | Florida | United States | 33030 |
44 | Nature Coast Clinical Research | Inverness | Florida | United States | 34452 |
45 | Savin Medical Group LLC | Miami Lakes | Florida | United States | 33014 |
46 | APF Research LLC | Miami | Florida | United States | 33134 |
47 | AMPM Research Clinic | Miami | Florida | United States | 33169 |
48 | Advanced Medical Research Institute | Miami | Florida | United States | 33174 |
49 | Florida Research Center, Inc. | Miami | Florida | United States | 33174 |
50 | American Research Institute, Inc | Miami | Florida | United States | 33175 |
51 | Gastroenterology Group of Naples | Naples | Florida | United States | 34102 |
52 | Sensible Healthcare | Ocoee | Florida | United States | 34761 |
53 | Synexus | Pinellas Park | Florida | United States | 33781 |
54 | Atlanta Diabetes Associates | Atlanta | Georgia | United States | 30318 |
55 | River Birch Research Alliance, LLC | Blue Ridge | Georgia | United States | 30513 |
56 | Gwinnett Research Institute, LLC | Buford | Georgia | United States | 30519 |
57 | Summit Clinical Research, LLC. | Carnesville | Georgia | United States | 30521 |
58 | iResearch Atlanta LLC | Decatur | Georgia | United States | 30030 |
59 | Infinite Clinical Trials | Riverdale | Georgia | United States | 30274 |
60 | Clinical Research Consultants of Atlanta | Suwanee | Georgia | United States | 30024 |
61 | Rocky Mountain Diabetes and Osteoporosis Center, PA | Idaho Falls | Idaho | United States | 83404-7596 |
62 | North Shore University Health System | Evanston | Illinois | United States | 60201 |
63 | Southwest Gastroenterology | Oak Lawn | Illinois | United States | 60453 |
64 | MediSphere Medical Research Center, LLC | Evansville | Indiana | United States | 47714 |
65 | Synexus Clinical Research US, Inc. | Evansville | Indiana | United States | 47714 |
66 | American Research, LLC | Jeffersonville | Indiana | United States | 47130 |
67 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
68 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
69 | Health Science Research Center | Pratt | Kansas | United States | 67124 |
70 | WestGlen Gastrointestinal Consultants | Shawnee Mission | Kansas | United States | 66217 |
71 | Cotton-O'Neil Clinical Research Center - Digestive Health | Topeka | Kansas | United States | 66606 |
72 | Kansas Medical Clinic | Topeka | Kansas | United States | 66606 |
73 | Professional Research Network of Kansas, LLC | Wichita | Kansas | United States | 67205 |
74 | Via Christi Clinic, PA | Wichita | Kansas | United States | 67208 |
75 | St. Elizabeth Healthcare â€" Clinical Research Institute | Erlanger | Kentucky | United States | 41018 |
76 | University of Louisville | Louisville | Kentucky | United States | 40202 |
77 | WK Physicians Network | Bossier City | Louisiana | United States | 71111 |
78 | Avant Research Associates LLC | Crowley | Louisiana | United States | 70526 |
79 | Cronola LLC | Houma | Louisiana | United States | 70360 |
80 | Clinical Trials of SWLA, LLC | Lake Charles | Louisiana | United States | 70601 |
81 | Tandem Clinical Research | Marrero | Louisiana | United States | 70072 |
82 | Clinical Trials of America, Inc. | West Monroe | Louisiana | United States | 71291 |
83 | Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research | Chevy Chase | Maryland | United States | 20815 |
84 | Gastro Center of Maryland | Columbia | Maryland | United States | 21045 |
85 | Frederick Gastroenterology Associates, PA an Elligo Health Research Site | Frederick | Maryland | United States | 21701 |
86 | Woodholme Gastroenterology Associates, P.A. | Glen Burnie | Maryland | United States | 21061 |
87 | Meritus Center for Clinical Research | Hagerstown | Maryland | United States | 21742 |
88 | Meridian Clinical Research, LLC | Rockville | Maryland | United States | 20854 |
89 | Clinical Research Institute of Michigan | Chesterfield | Michigan | United States | 48047 |
90 | Vida Clinical Studies | Dearborn | Michigan | United States | 48124 |
91 | Aa Mrc, Llc | Flint | Michigan | United States | 48504 |
92 | National Clinical, LLC | Hamtramck | Michigan | United States | 48212 |
93 | Gastroenterology Associates of Western Michigan, West Michigan Clinical Research Center | Wyoming | Michigan | United States | 49519 |
94 | MNGI Digestive Health | Coon Rapids | Minnesota | United States | 55446 |
95 | Synexus Clinical Research US, Inc. | Richfield | Minnesota | United States | 55423 |
96 | Synexus Clinical Research US, Inc | Saint Louis | Missouri | United States | 63141 |
97 | Montana Medical Research | Missoula | Montana | United States | 59808 |
98 | Diabetes and Endocrine Associates, P.C. | Omaha | Nebraska | United States | 68114 |
99 | Heartland Clinical Research, Inc | Omaha | Nebraska | United States | 68134 |
100 | Excel Clinical Research | Las Vegas | Nevada | United States | 89109 |
101 | Clinical Research of South Nevada - CROSN | Las Vegas | Nevada | United States | 89121 |
102 | Advanced Biomedical Research of America | Las Vegas | Nevada | United States | 89123 |
103 | Digestive Disease Specialists | Las Vegas | Nevada | United States | 89128 |
104 | Palm Research Center | Las Vegas | Nevada | United States | 89135 |
105 | Garden State Endocrinology LLC | Brick | New Jersey | United States | 08723 |
106 | Synexus Clinical Research US, Inc. | Bridgeton | New Jersey | United States | 08302 |
107 | AGA Clinical Research Associates, LLC | Egg Harbor Township | New Jersey | United States | 08234 |
108 | Lovelace Scientific Resources, Inc. | Albuquerque | New Mexico | United States | 87108 |
109 | CHEAR Center LLC | Bronx | New York | United States | 10455 |
110 | Long Island Gastrointestinal Research Group LLP | Great Neck | New York | United States | 11023 |
111 | United Health Services Hospitals, Inc. | Johnson City | New York | United States | 13790 |
112 | Asheville Gastroenterology Associates | Asheville | North Carolina | United States | 28801 |
113 | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27599-7080 |
114 | Carolinas Healthcare-Charlotte | Charlotte | North Carolina | United States | 28204 |
115 | Carolina Digestive Health Associates, PA | Concord | North Carolina | United States | 28025 |
116 | Cumberland Research Associates, LLC | Fayetteville | North Carolina | United States | 28304 |
117 | Triad Clinical Trials | Greensboro | North Carolina | United States | 27410 |
118 | Vidant Multispeciality Clinic - Kinston | Kinston | North Carolina | United States | 28501 |
119 | Diabetes and Endocrinology Consultants, PC | Morehead City | North Carolina | United States | 28557 |
120 | PMG Research Salisbury | Salisbury | North Carolina | United States | 28144 |
121 | PMG Research of Wilmington, LLC | Wilmington | North Carolina | United States | 28401 |
122 | Trial Management Associates, LLC | Wilmington | North Carolina | United States | 28403 |
123 | PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | United States | 27103 |
124 | The Center for Clinical Research | Winston-Salem | North Carolina | United States | 27103 |
125 | Synexus Clinical Research US, Inc. | Akron | Ohio | United States | 44311 |
126 | Dayton Gastroenterology,Inc. | Beavercreek | Ohio | United States | 45440 |
127 | Diabetes & Endocrinology Associates of Stark County, Inc. | Canton | Ohio | United States | 44718 |
128 | Synexus Clinical Research US - Cincinnati | Cincinnati | Ohio | United States | 45236 |
129 | Synexus Clinical Research US, Inc | Cincinnati | Ohio | United States | 45249 |
130 | Endocrinology Research Associates, Inc. | Columbus | Ohio | United States | 43201 |
131 | The Ohio State University, Wexner Medical Center | Columbus | Ohio | United States | 43203 |
132 | Aventiv Research, Inc. | Columbus | Ohio | United States | 43213 |
133 | Hometown Urgent Care and Research | Columbus | Ohio | United States | 43214 |
134 | CIC America Clinical Inquest Center Ltd. | Dayton | Ohio | United States | 45409 |
135 | Hometown Urgent Care and Research | Dayton | Ohio | United States | 45424 |
136 | Premier Clinical Research d.b.a. STAT Research | Franklin | Ohio | United States | 45005 |
137 | Family Practice Center of Wadsworth, Inc. | Wadsworth | Ohio | United States | 44281 |
138 | Centennial Health-Synexus | Oklahoma City | Oklahoma | United States | 73111 |
139 | Digestive Disease Specialists Inc | Oklahoma City | Oklahoma | United States | 73112 |
140 | Memorial Clinical Research | Oklahoma City | Oklahoma | United States | 73120 |
141 | Options Health Research, LLC | Tulsa | Oklahoma | United States | 74104 |
142 | Northwest Gastroenterology Clinic, LLC | Portland | Oregon | United States | 97210 |
143 | Family Medical Associates, Research Department | Levittown | Pennsylvania | United States | 19056 |
144 | Allegheny Endocrinology Associates | Pittsburgh | Pennsylvania | United States | 15212 |
145 | Preferred Primary Care Physicians, Inc. | Pittsburgh | Pennsylvania | United States | 15236 |
146 | Guthrie Clinical Research | Sayre | Pennsylvania | United States | 18840 |
147 | Frontier Clinical Research, LLC | Scottdale | Pennsylvania | United States | 15683 |
148 | Frontier Clinical Research, LLC | Smithfield | Pennsylvania | United States | 15478 |
149 | Preferred Primary Care Physicians | Uniontown | Pennsylvania | United States | 15401 |
150 | Synexus Clinical Research US, Inc. | Anderson | South Carolina | United States | 29621 |
151 | Synexus Clinical Research US, Inc | Anderson | South Carolina | United States | 29621 |
152 | Clinical Trials of South Carolina | Charleston | South Carolina | United States | 29406 |
153 | Carolina Medical Research | Clinton | South Carolina | United States | 29325 |
154 | Gastroenterology Associates, PA | Greenville | South Carolina | United States | 29615 |
155 | Synexus Clinical Research | Greer | South Carolina | United States | 29650 |
156 | Health Concepts | Rapid City | South Dakota | United States | 57702 |
157 | Clinsearch | Chattanooga | Tennessee | United States | 37421 |
158 | Gastroenterology Centers of the Midsouth | Germantown | Tennessee | United States | 38138 |
159 | East Tennessee Research Institute | Johnson City | Tennessee | United States | 37604 |
160 | Quality Medical Research | Nashville | Tennessee | United States | 37211 |
161 | Texas Clinical Research Institute, LLC | Arlington | Texas | United States | 76012 |
162 | DiscoveResearch, Inc. | Beaumont | Texas | United States | 77701 |
163 | ClinRx Research, LLC | Carrollton | Texas | United States | 75007 |
164 | Baylor College of Medicine Medical Center | Houston | Texas | United States | 77030 |
165 | Biopharma Informatic Inc., Research Center | Houston | Texas | United States | 77043 |
166 | Houston Endoscopy and Research Center, Inc. | Houston | Texas | United States | 77079 |
167 | Rodriguez Clinical Trials | Houston | Texas | United States | 77083 |
168 | Amir Hassan, MD, PA | Houston | Texas | United States | 77089 |
169 | Sante Clinical Research | Kerrville | Texas | United States | 78028 |
170 | Pinnacle Clinical Research | San Antonio | Texas | United States | 78215 |
171 | Clinical Trials of Texas, Inc. | San Antonio | Texas | United States | 78229 |
172 | Sagact Pllc. | San Antonio | Texas | United States | 78229 |
173 | Synexus Clinical Research US, Inc. | San Antonio | Texas | United States | 78229 |
174 | Synexus Clinical Research US, Inc. | Layton | Utah | United States | 84041 |
175 | Synexus Clinical Research US, Inc. | Murray | Utah | United States | 84123 |
176 | Advanced Research Institute, Inc. | Ogden | Utah | United States | 84405 |
177 | Advanced Clinical Research | West Jordan | Utah | United States | 84088 |
178 | Verity Research Inc. | Fairfax | Virginia | United States | 22031 |
179 | Blue Ridge Medical Research | Lynchburg | Virginia | United States | 24502 |
180 | Manassas Clinical Research Centre | Manassas | Virginia | United States | 20110 |
181 | VA Medical Center McGuire VAMC | Richmond | Virginia | United States | 23249 |
182 | Washington Gastroenterology PLLC | Tacoma | Washington | United States | 98405 |
183 | West Virginia University | Morgantown | West Virginia | United States | 26506 |
184 | Consultorios Asociados de Endocrinologia e Investigación Cl | Buenos Aires | Buenos Aires Province | Argentina | C1425AGC |
185 | Hospital Sirio Libanes | Caba | Buenos Aires Province | Argentina | C1419AHN |
186 | Centro de Investigaciones Medicas Mar del Plata SRL | Mar del Plata | Buenos Aires | Argentina | B7600FYK |
187 | CIPREC | Buenos Aires | Ciudad Autonoma deBuenos Aires | Argentina | 1119 |
188 | Instituto de Investigaciones Clinicas de Rosario | Rosario | Santa Fe | Argentina | S2000BIE |
189 | Instituto Medico Catamarca-I.ME.C | Rosario | Santa Fe | Argentina | S200CFK |
190 | Clinica Mayo de Urgencias Medicas Cruz Blanca SRL | San Miguel de Tucuman | Tucuman | Argentina | 4000 |
191 | CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian | Cordoba | Argentina | X5000BNB | |
192 | Centro Universitario de Investigacion en Farmacologia Clinic | Corrientes | Argentina | W3410AVV | |
193 | Instituto Privado de Investigaciones Clinicas de Cordoba | Córdoba | Argentina | X5000AAW | |
194 | Nepean Hospital | Kingswood | New South Wales | Australia | 2747 |
195 | Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated | Adelaide | South Australia | Australia | 5000 |
196 | Royal Melbourne Hospital | Parkville | Victoria | Australia | 3050 |
197 | Ordination | Osterreicher | Steiermark | Austria | 8511 |
198 | VIVIT Institute, am LKH Feldkirch | Feldkirch | Vorarlberg | Austria | 6807 |
199 | Privatklinik wehlre-Diakonissen | Salzburg | Austria | 5020 | |
200 | Oö. Gesundheits- und Spitals-AG/LKH Steyr | Steyr | Austria | 4400 | |
201 | Universitair Ziekenhuis Antwerpen, Gastro-Enterologie, | Edegem | Antwerp | Belgium | 2650 |
202 | UZ Brussel | Jette | Brussel | Belgium | 1090 |
203 | AZ Sint Lucas Brugge | Brugge | West-Vlaanderen | Belgium | 8310 |
204 | Hospital Universitário Walter Cantídio | Fortaleza | CE | Brazil | 60430-270 |
205 | Centro de Pesquisa Clinica do Brasil | Brasilia | Distrito Federal | Brazil | 71625175 |
206 | Hospital Universitário João de Barros Barreto - UFPA | Belem | PA | Brazil | 66073-005 |
207 | Núcleo de Pesquisa Clínica do Rio Grande do Sul | Porto Alegre | Rio Grande Do Sul | Brazil | 90430-001 |
208 | Instituto Catarinense de Endocrinologia e Diabetes (ICED) | Joinville | Santa Catarina | Brazil | 89201-260 |
209 | Scentryphar Pesquisa Clínica Ltda | Campinas | Sao Paulo | Brazil | 13020-431 |
210 | Instituto de Pesquisa Clinica em Campinas | Campinas | Sao Paulo | Brazil | 13060-080 |
211 | Instituto de Estudos e Pesquisas Clinicas do Ceara IEP/CE - Oncology | Fortaleza | Brazil | 60160-230 | |
212 | IPEC-Instituto de Pesquisa Clinica | Sao Paulo | Brazil | 01223-001 | |
213 | CPQuali Pesquisa Clinica Ltda | Sao Paulo | Brazil | 01228-000 | |
214 | MHAT Yuliya Vrevska Byala | Byala | Ruse | Bulgaria | 7100 |
215 | UMHAT - Kaspela- EOOD | Plovdiv | Bulgaria | 4002 | |
216 | Medical Center Asklepion - Humane Medicine Research EOOD | Sofia | Bulgaria | 1303 | |
217 | Alexandrovska University Hospital | Sofia | Bulgaria | 1431 | |
218 | University of Calgary | Calgary | Alberta | Canada | T2N 2T9 |
219 | Central Alberta Research Centre | Red Deer | Alberta | Canada | T4N 6V7 |
220 | Vancouver General Hospital | Vancouver | British Columbia | Canada | V5Z 1M9 |
221 | Patient research centre | St. John's | Newfoundland and Labrador | Canada | A1B 3V6 |
222 | South Shore Medical Arts | Bridgewater | Nova Scotia | Canada | B4V 3N2 |
223 | The Ottawa Hospital | Ottawa | Ontario | Canada | K1H 7W9 |
224 | Toronto Digestive Disease Associates, Inc. | Vaughan | Ontario | Canada | L4L 4Y7 |
225 | Recherche GCP Research | Montreal | Quebec | Canada | H1M 1B1 |
226 | Centro Cardiovascular Colombiano Clínica Santa María | Medellin | Antioquia | Colombia | 050034 |
227 | Rodrigo Botero S.A.S. | Medellín | Antioquia | Colombia | 050030 |
228 | Centro Cardiovascular y de Diabetes | Barranquilla | Atlantico | Colombia | 080020 |
229 | Fundación del Caribe para la InvestigacionBiomédica-Fundación BIOS | Barranquilla | Atlantico | Colombia | 080020 |
230 | Asociación Colombiana de Diabetes | Bogotá | Cundinamarca | Colombia | 111311 |
231 | Healthy Medical Center | Zipaquira | Cundinamarca | Colombia | 250252 |
232 | Endocare Ltda. | Bogotá | Distrito Capital De Bogotá | Colombia | 111111 |
233 | Medplus Centro de Recuperacion Integral S.A.S. | Bogotá | Distrito Capital | Colombia | 110221 |
234 | Centro de Investigaciones Clínicas IPS CARDIOMET Pereira | Pereira | Risaralda | Colombia | 660003 |
235 | IPS Centro Medico Julian Coronel S.A | Cali | Valle Del Cauca | Colombia | 760035 |
236 | Centro Medico Imbanaco de Cali S.A. | Cali | Valle Del Cauca | Colombia | 760042 |
237 | Steno Diabetes Center Copenhagen | Hellerup | Copenhagen | Denmark | 2900 |
238 | Gastroenheden, Hvidovre hospital | Hvidovre | København | Denmark | 2605 |
239 | Klinische Forschung Karlsruhe GmbH | Karlsruhe | Baden-Wurttemberg | Germany | 76199 |
240 | Studienzentrum Schwittay | Böhlen | Saxony | Germany | 4564 |
241 | Klinische Forschung Dresden GmbH | Dresden | Saxony | Germany | 1309 |
242 | Clinical Research Hamburg | Hamburg | Germany | 22143 | |
243 | Israelitisches Krankenhaus | Hamburg | Germany | 22297 | |
244 | KRH Klinikum Siloah | Hannover | Germany | 30459 | |
245 | Markhot Ferenc Oktatokorhaz es Rendelointezet | Eger | Heves | Hungary | H-3300 |
246 | Hetenyi Geza Hospital | Szolnok | Jász-Nagykun-Szolnok | Hungary | H-5004 |
247 | Zala Megyei Szent Rafael Korhaz | Zalaegerszeg | Zala | Hungary | H-8900 |
248 | Strázsahegy Gyógyszertár Medicina | Budapest | Hungary | H1171 | |
249 | Szegedi TudomanyegyetemSzent-Gyorgyi Albert Klinikai Kozpont és Altalanos Orvostudomanyi Kar Belgyogyaszati Klinika | Szeged | Hungary | H-6720 | |
250 | Kumudini Devi Diabetes Research Center; Ramdevrao Hospital | Hyderabad | Andhra Pradesh | India | 500072 |
251 | King George Hospital | Visakhapatnam | Andhra Pradesh | India | 530002 |
252 | Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology | Ahmedabad | Gujarat | India | 380007 |
253 | Zydus Hospital | Ahmedabad | Gujarat | India | 380054 |
254 | Lifecare Clinic and Research Centre - Internal Med/Diabetology | Bangalore | Karnataka | India | 560092 |
255 | Diacon Hospital and research Center - Diabetology | Bengaluru | Karnataka | India | 359-360 |
256 | Victoria Hospital Bangalore Medical College and Research Institute | Bengaluru | Karnataka | India | 560002 |
257 | Rajalakshmi Hospital | Bengaluru | Karnataka | India | 560097 |
258 | Bhatia Hospital | Mumbai | Maharashtra | India | 400007 |
259 | B. J. Government Medical College and Sassoon General Hospitals | Pune | Maharashtra | India | 411001 |
260 | Universal Hospital | Pune | Maharashtra | India | 411011 |
261 | Noble Hospital | Pune | Maharashtra | India | 411013 |
262 | S R Kalla (SRK) Memorial Gastro & General Hospital | Jaipur | Rajasthan | India | 302001 |
263 | Marudhar Hospital | Jaipur | Rajasthan | India | 302012 |
264 | Eternal Hospital - Diabetology | Jaipur | Rajasthan | India | 302017 |
265 | SMS Hospital | Jaipur | Rajasthan | India | 302017 |
266 | M.V. Hospital for Diabetes & Diabetes Research Centre | Chennai | Tamil Nadu | India | 600013 |
267 | Kovai Diabetes Speciality Centre | Coimbatore | Tamil Nadu | India | 641009 |
268 | Arthur Asirvatham Hospital | Madurai | Tamil Nadu | India | 625020 |
269 | M V Hospital & Research Centre | Lucknow | Uttar Pradesh | India | 226003 |
270 | Sir Ganga Ram Hospital (SGRH) | Delhi | India | 110060 | |
271 | Vinaya Hospital & Research Centre | Mangalore | India | 575003 | |
272 | Bnei-Zion MC | Haifa | Israel | 31948 | |
273 | Chonbuk National University Hospital | Jeonju | Jeollabuk-Do | Korea, Republic of | 561-712 |
274 | Sanggye Paik Hospital, Inje University College of Medicine | Seoul | Nowon-gu | Korea, Republic of | 1757 |
275 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
276 | Kraslava Hospital | Kraslava | Kraslavas Nov. | Latvia | 5601 |
277 | Polana-D | Daugavpils | Latvia | LV5401 | |
278 | Pauls Stradins Clinical University Hospital, Endokrinologijas nodala | Riga | Latvia | 1002 | |
279 | Digestive Diseases Centre GASTRO | Riga | Latvia | 1006 | |
280 | Hospital Sultanah Bahiyah | Alor Setar | Kedah | Malaysia | 5460 |
281 | Clinical Investigation Centre | Kuala Lumpur | Malaysia | 59100 | |
282 | Clinical Trial Unit, School of Medical Sciences, Health Campus, Hospital Universiti Sains Malaysia | Kubang Kerian | Malaysia | 16150 | |
283 | Hospital Taiping | Taiping | Malaysia | 34000 | |
284 | Mentrials Sa de Cv | Mexico DF | Distrito Federal | Mexico | 06700 |
285 | Clinicos Asociados BOCM SC | Mexico | Distrito Federal | Mexico | 03300 |
286 | Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology | Mexico | Distrito Federal | Mexico | 11650 |
287 | Centro de Atención e Investigación en Factores de Riesgo Car | Mexico | Distrito Federal | Mexico | 14000 |
288 | Unidad de Investigacion Clinica Cardiometabolica de Occidente | Guadalajara | Jalisco | Mexico | 44150 |
289 | Consultorio particular | Guadalajara | Jalisco | Mexico | 44210 |
290 | Unidad de Investigación Clínica en Medicina S.C/ | Guadalajara | Jalisco | Mexico | 44670 |
291 | Centro de Desarrollo Biomédico S.C.P | Mérida | Yucatán | Mexico | 97070 |
292 | Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV | Aguascalientes | Mexico | 20230 | |
293 | Hospital Cardiologica Aguascalientes | Aguascalientes | Mexico | 20230 | |
294 | Dioderm Instituto de Investigacion | Durango | Mexico | 34060 | |
295 | CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición) | Durango | Mexico | 34270 | |
296 | Sociedad de Metabolismo y Corazon S.C. | Veracruz | Mexico | 91900 | |
297 | West Visayas State University Medical Center | IloIlo City | IloIlo | Philippines | 5000 |
298 | Cardinal Santos Medical Center | San Juan City | Metro Manila | Philippines | 1502 |
299 | Manila Doctors Hospital, Ermita | Manila | Metropolitan Manila | Philippines | 1000 |
300 | San Juan De Dios Educational Foundation, Inc. | Pasay | Metropolitan Manila | Philippines | 1300 |
301 | Ospital ng Makati | Makati City | NCR | Philippines | 1218 |
302 | Perpetual Succor Hospital | Cebu City | Philippines | 6000 | |
303 | St. Luke's Medical Center | Quezon City | Philippines | 1100 | |
304 | Specjalistyczny Gabinet Neurologiczny Marta Banach | Kraków | Lesser Poland | Poland | 30-539 |
305 | CenterMed Krakow Ltd | Krakow | Malopolska | Poland | 31-530 |
306 | Centrum Medyczne Lukamed | Chojnice | Poland | 89-600 | |
307 | Saint-Petersburg City Pokrovskaya Hospital | St-Petersburg | Leningrad Region | Russian Federation | 199106 |
308 | GUZ Saratov City Clinical Hospital 9 | Saratov | Saratov Region | Russian Federation | 410030 |
309 | Scientific Institute of Clinical and Experimental Lymphology | Novosibirsk | Russian Federation | 630117 | |
310 | Rostov on Don | Rostov on Don | Russian Federation | 344019 | |
311 | National University Hospital | Singapore | Singapore | 119228 | |
312 | Changi General Hospital | Singapore | Singapore | 529889 | |
313 | Singapore General Hospital | Singapore | Singapore | S169856 | |
314 | FARMOVS | Bloemfontein | Free State | South Africa | 9301 |
315 | Wits Clinical Research | Johannesburg | Gauteng | South Africa | 2193 |
316 | Synexus Stanza Clinical Research Centre | Pretoria | Gauteng | South Africa | 0122 |
317 | Watermeyer Clinical Research Site | Pretoria | Val De Grace | South Africa | 0184 |
318 | Synexus Helderberg Clinical Research Centre | Somerset West | South Africa | 7130 | |
319 | Hospital Universitario Principe de Asturias | Madrid | Spain | 28850 | |
320 | Phramongkutklao Hospital | Bangkok | Thailand | 10400 | |
321 | Faculty of Medicine, Siriraj Hospital, Mahidol University | Bangkok | Thailand | 10700 | |
322 | Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | Thailand | 50200 | |
323 | State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine | Dnipro | Dnipropetrovs'ka Oblast' | Ukraine | 49027 |
324 | Municipal Institution, City Hospital #7, polyclinic department, c. Zaporizhzhia | Zaporizhzhia | Zaporizhzhia Region | Ukraine | 69600 |
325 | Chernivtsi Regional Clinical Hospital | Chernivtsi | Ukraine | 58001 | |
326 | Regional Municipal noncommercial Enterprise "Chernivtsi Regional Endocrinology Center", Polyclinic department, Higher State Educational Establishment of Ukraine "Bukovinian State Medical University", Department of Clinical Immunology, Allergology and Endo | Chernivtsi | Ukraine | 58022 | |
327 | Ivano-Frankivsk National Medical University | Ivano-Frankivsk | Ukraine | 76008 | |
328 | Ivano-Frankivsk Central City Clinical Hospital | Ivano-Frankivsk | Ukraine | 76018 | |
329 | Municipal nonprofit entity of Kharkiv municipal council | Kharkiv | Ukraine | 61037 | |
330 | Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine" | Kharkiv | Ukraine | 61070 | |
331 | Communal Institution Kherson City Clinical Hospital | Kherson | Ukraine | 73000 | |
332 | Kyiv Railway Clinical Hospital No-2 of Branch of Healthcare Center of the PJSC Ukrainian Railway , Endocrynology Department | Kyiv | Ukraine | 3049 | |
333 | Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit | Kyiv | Ukraine | 4050 | |
334 | Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University | Odesa | Ukraine | 65010 | |
335 | Poltava Regional Clinical Hospital | Poltava | Ukraine | 36011 | |
336 | Private Small-Scale Enterprise Medical Centre Pulse | Vinnytsia | Ukraine | 21001 | |
337 | Vinnytsia Regional Clinical highly specialized Endocrinology Centre | Vinnytsia | Ukraine | 21010 | |
338 | Municipal Institution 6th City Clinical Hospital, Dept of Gastroenterology | Zaporizhzhia | Ukraine | 69035 | |
339 | Biomedical Research Centre | Nottingham | East Midland | United Kingdom | NG7 2UH |
340 | MAC Clinical Research Manchester | Manchester | Greater Manchester | United Kingdom | M13 9NQ |
341 | Royal Oldham Hospital | Oldham | Lancashire | United Kingdom | OL1 2JH |
342 | MAC Clinical Research | Liverpool | Merseyside | United Kingdom | L34 1BH |
343 | MAC Research, Exchange House | Cannock | Staffordshire | United Kingdom | WS11 0BH |
344 | University Hospitals of North Midlands | Stoke on Trent | Staffordshire | United Kingdom | ST6 8DG |
345 | MAC Clinical Research, Monarch House | Leeds | West Yorkshire | United Kingdom | LS10 1DU |
346 | MAC Research | Barnsley | United Kingdom | S75 3DL | |
347 | MAC Clinical Research, Kaman Court | Blackpool | United Kingdom | FY2 0JH | |
348 | Mid Essex Hospital Services NHS Trust Broomfield Hospital | Chelmsford | United Kingdom | CM1 7ET | |
349 | MAC Clinical Research, GAC House | Manchester | United Kingdom | M13 9NQ |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Harvy Schneier, Allergan
Study Documents (Full-Text)
More Information
Publications
None provided.- RLM-MD-04
- 2017-002144-33
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | Participants who completed the placebo run-in of relamorelin studies: RLM-MD-01 [NCT03285308] and RLM-MD-02 [NCT03426345] were eligible to rollover to this study. De novo (New) participants, who had not participated in the previous studies, were also eligible for enrollment. |
Arm/Group Title | Placebo | Relamorelin 10 μg |
---|---|---|
Arm/Group Description | Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. | Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. |
Period Title: Overall Study | ||
STARTED | 148 | 302 |
Safety Population | 145 | 299 |
Run-in Period | 91 | 207 |
COMPLETED | 63 | 118 |
NOT COMPLETED | 85 | 184 |
Baseline Characteristics
Arm/Group Title | Placebo | Relamorelin 10 μg | Total |
---|---|---|---|
Arm/Group Description | Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. | Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. | Total of all reporting groups |
Overall Participants | 148 | 302 | 450 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
57.0
(12.37)
|
57.9
(11.57)
|
57.6
(11.84)
|
Sex: Female, Male (Count of Participants) | |||
Female |
102
68.9%
|
224
74.2%
|
326
72.4%
|
Male |
46
31.1%
|
78
25.8%
|
124
27.6%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
50
33.8%
|
82
27.2%
|
132
29.3%
|
Not Hispanic or Latino |
98
66.2%
|
220
72.8%
|
318
70.7%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
7
4.7%
|
11
3.6%
|
18
4%
|
Asian |
0
0%
|
9
3%
|
9
2%
|
Native Hawaiian or Other Pacific Islander |
1
0.7%
|
0
0%
|
1
0.2%
|
Black or African American |
27
18.2%
|
53
17.5%
|
80
17.8%
|
White |
109
73.6%
|
218
72.2%
|
327
72.7%
|
More than one race |
4
2.7%
|
11
3.6%
|
15
3.3%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
Title | Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) |
---|---|
Description | Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants. |
Time Frame | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 12 of this study |
Outcome Measure Data
Analysis Population Description |
---|
Modified-intent-to-treat (mITT) Population included all randomized participants with ≥1 postbaseline assessment of DGSSD. Number analyzed is the number of participants with data available for analysis at the given timepoint. |
Arm/Group Title | Placebo | Relamorelin 10 μg |
---|---|---|
Arm/Group Description | Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. | Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. |
Measure Participants | 147 | 295 |
Baseline |
20.3
(6.70)
|
19.7
(6.39)
|
Change from Baseline to Week 12 |
-7.1
(8.82)
|
-6.5
(7.80)
|
Title | Change From Baseline to Week 52 in the Weekly Average DGSSS |
---|---|
Description | Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). The average weekly scores at Week 52 were the average of the DGSSS scores from Week 49 to Week 52. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants. |
Time Frame | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 52 of this study |
Outcome Measure Data
Analysis Population Description |
---|
mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD. Number analyzed is the number of participants with data available for analysis at the given timepoint. |
Arm/Group Title | Placebo | Relamorelin 10 μg |
---|---|---|
Arm/Group Description | Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. | Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. |
Measure Participants | 147 | 295 |
Baseline |
20.3
(6.70)
|
19.7
(6.39)
|
Change from Baseline to Week 52 |
-10.7
(8.93)
|
-8.6
(8.92)
|
Title | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) |
---|---|
Description | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug. |
Time Frame | First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks) |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all participants who received ≥1 administration of study treatment. |
Arm/Group Title | Placebo | Relamorelin 10 μg |
---|---|---|
Arm/Group Description | Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. | Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. |
Measure Participants | 145 | 299 |
Count of Participants [Participants] |
105
70.9%
|
221
73.2%
|
Title | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results |
---|---|
Description | Clinical Laboratory tests included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 participant had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported. |
Time Frame | Up to 52 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all participants who received ≥1 administration of study treatment. Number analyzed is the number of participants with non-PCS Baseline values and at least one post-baseline assessment. |
Arm/Group Title | Placebo | Relamorelin 10 μg |
---|---|---|
Arm/Group Description | Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. | Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. |
Measure Participants | 145 | 299 |
Hematocrit (RATIO): >1.1×Upper Limit of Normal Value (ULN) |
0
0%
|
1
0.3%
|
Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN) |
5
3.4%
|
14
4.6%
|
Hemoglobin (gram(g)/L): <0.9×LLN |
10
6.8%
|
20
6.6%
|
Lymphocytes Absolute Cell Count (10^9/(Liter(L)): >1.5×ULN |
1
0.7%
|
5
1.7%
|
Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN |
2
1.4%
|
9
3%
|
Mean Corpuscular Volume [femtoliter(fL)]: >1.1×ULN |
2
1.4%
|
2
0.7%
|
Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN |
2
1.4%
|
0
0%
|
Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN |
7
4.7%
|
3
1%
|
Red Blood Cell Count (10^12/L):<0.9×LLN |
2
1.4%
|
10
3.3%
|
White Blood Cell Count (10^9/L): <0.7×LLN |
2
1.4%
|
0
0%
|
Alanine Aminotransferase (Serum Glutamate-Pyruvate transaminase (SGPT)) (Unit (U)/L): ≥3.0×ULN |
0
0%
|
6
2%
|
Albumin (gram (g)/L): <0.9×LLN |
0
0%
|
1
0.3%
|
Alkaline Phosphatase (U/L): ≥3.0×ULN |
0
0%
|
1
0.3%
|
Aspartate Aminotransferase (Serum Glutamic-Oxaloacetic Transaminase (SGOT)) (U/L): ≥3.0×ULN |
2
1.4%
|
3
1%
|
Bicarbonate (HCO3) (millimole (mmol)/L): >1.1×ULN |
3
2%
|
2
0.7%
|
Bicarbonate (HCO3) (millimole (mmol)/L): >1.1×LLN |
3
2%
|
2
0.7%
|
Bicarbonate (HCO3) (millimole (mmol)/L): <0.9×LLN |
6
4.1%
|
6
2%
|
Bilirubin, Total (micromole (umol)/L): >1.5×ULN |
0
0%
|
1
0.3%
|
Blood Urea Nitrogen (mmol/L): >1.2×ULN |
14
9.5%
|
27
8.9%
|
Calcium (mmol/L): >1.1×ULN |
0
0%
|
1
0.3%
|
Chloride (mmol/L): <0.9×LLN |
1
0.7%
|
1
0.3%
|
Cholesterol, Total, Fasting (mmol/L): >1.6×ULN |
2
1.4%
|
5
1.7%
|
Creatinine (umol/L): >1.3×ULN |
15
10.1%
|
20
6.6%
|
Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN |
22
14.9%
|
52
17.2%
|
Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN |
4
2.7%
|
14
4.6%
|
Glycohemoglobin A1C (%): Increase of ≥0.5% |
95
64.2%
|
247
81.8%
|
Glycohemoglobin A1C (%): Increase of ≥1% |
94
63.5%
|
246
81.5%
|
Phosphorus (mmol/L): >1.1×ULN |
13
8.8%
|
5
1.7%
|
Phosphorus (mmol/L): <0.9×LLN |
1
0.7%
|
4
1.3%
|
Potassium (mmol/L): <0.9×LLN |
1
0.7%
|
0
0%
|
Protein, Total (g)/L): >1.1×ULN |
1
0.7%
|
0
0%
|
Triglycerides, Fasting (mmol/L): ≥3.0×ULN |
8
5.4%
|
9
3%
|
Uric Acid (Urate) (umol/L): >1.1×ULN |
17
11.5%
|
37
12.3%
|
Uric Acid (Urate) (umol/L): <0.9×LLN |
1
0.7%
|
9
3%
|
Title | Number of Participants With Clinically Meaningful Trends for Vital Signs |
---|---|
Description | Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant. |
Time Frame | Up to 52 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all participants who received ≥1 administration of study treatment. |
Arm/Group Title | Placebo | Relamorelin 10 μg |
---|---|---|
Arm/Group Description | Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. | Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. |
Measure Participants | 145 | 299 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
Title | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results |
---|---|
Description | A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant. |
Time Frame | Up to 52 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all participants who received ≥1 administration of study treatment. |
Arm/Group Title | Placebo | Relamorelin 10 μg |
---|---|---|
Arm/Group Description | Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. | Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. |
Measure Participants | 145 | 299 |
Count of Participants [Participants] |
2
1.4%
|
2
0.7%
|
Title | Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HbA1c) |
---|---|
Description | |
Time Frame | Up to 52 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all participants who received ≥1 administration of study treatment. |
Arm/Group Title | Placebo | Relamorelin 10 μg |
---|---|---|
Arm/Group Description | Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. | Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. |
Measure Participants | 145 | 299 |
Count of Participants [Participants] |
94
63.5%
|
246
81.5%
|
Title | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit |
---|---|
Description | A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point. |
Time Frame | Baseline (Day 1), Day 84, Day 364, and End of Treatment (Up to Day 364) |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all participants who received ≥1 administration of double-blind study treatment (N=299 in the Relamorelin 10 μg arm). Anti-relamorelin antibody testing was only done for those participants who received treatment with relamorelin. Number analyzed is the number of participants with data available at the given timepoint. Due to a laboratory issue not all positive screening tests were confirmed. |
Arm/Group Title | Relamorelin 10 μg |
---|---|
Arm/Group Description | Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. |
Measure Participants | 299 |
Negative |
127
85.8%
|
Positive |
39
26.4%
|
Negative |
5
3.4%
|
Positive |
0
0%
|
Negative |
73
49.3%
|
Positive |
23
15.5%
|
Negative |
6
4.1%
|
Positive |
1
0.7%
|
Negative |
10
6.8%
|
Positive |
4
2.7%
|
Negative | |
Positive | |
Negative |
20
13.5%
|
Positive |
6
4.1%
|
Negative |
1
0.7%
|
Positive |
0
0%
|
Negative |
2
1.4%
|
Positive |
1
0.7%
|
Negative |
1
0.7%
|
Positive |
0
0%
|
Adverse Events
Time Frame | First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks) | |||
---|---|---|---|---|
Adverse Event Reporting Description | All-Cause Mortality included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 administration of study treatment. | |||
Arm/Group Title | Placebo | Relamorelin 10 μg | ||
Arm/Group Description | Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. | Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. | ||
All Cause Mortality |
||||
Placebo | Relamorelin 10 μg | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/148 (0%) | 2/302 (0.7%) | ||
Serious Adverse Events |
||||
Placebo | Relamorelin 10 μg | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 21/145 (14.5%) | 43/299 (14.4%) | ||
Cardiac disorders | ||||
Cardiac arrest | 0/145 (0%) | 2/299 (0.7%) | ||
Acute left ventricular failure | 1/145 (0.7%) | 1/299 (0.3%) | ||
Acute myocardial infarction | 0/145 (0%) | 1/299 (0.3%) | ||
Angina pectoris | 0/145 (0%) | 1/299 (0.3%) | ||
Angina unstable | 0/145 (0%) | 1/299 (0.3%) | ||
Arteriosclerosis coronary artery | 0/145 (0%) | 1/299 (0.3%) | ||
Atrial fibrillation | 0/145 (0%) | 1/299 (0.3%) | ||
Bradycardia | 0/145 (0%) | 1/299 (0.3%) | ||
Myocardial infarction | 0/145 (0%) | 1/299 (0.3%) | ||
Cardiac failure | 1/145 (0.7%) | 0/299 (0%) | ||
Sinus tachycardia | 1/145 (0.7%) | 0/299 (0%) | ||
Congenital, familial and genetic disorders | ||||
Atrial septal defect | 0/145 (0%) | 1/299 (0.3%) | ||
Ear and labyrinth disorders | ||||
Vertigo | 0/145 (0%) | 2/299 (0.7%) | ||
Gastrointestinal disorders | ||||
Pancreatitis | 1/145 (0.7%) | 1/299 (0.3%) | ||
Large intestine perforation | 0/145 (0%) | 1/299 (0.3%) | ||
Abdominal pain upper | 1/145 (0.7%) | 0/299 (0%) | ||
Constipation | 1/145 (0.7%) | 0/299 (0%) | ||
Diabetic gastroparesis | 1/145 (0.7%) | 0/299 (0%) | ||
Nausea | 1/145 (0.7%) | 0/299 (0%) | ||
General disorders | ||||
Non-cardiac chest pain | 0/145 (0%) | 2/299 (0.7%) | ||
Physical deconditioning | 0/145 (0%) | 1/299 (0.3%) | ||
Hepatobiliary disorders | ||||
Cholelithiasis | 0/145 (0%) | 2/299 (0.7%) | ||
Cholecystitis | 1/145 (0.7%) | 0/299 (0%) | ||
Infections and infestations | ||||
Bronchitis | 0/145 (0%) | 2/299 (0.7%) | ||
Diverticulitis | 0/145 (0%) | 2/299 (0.7%) | ||
Sepsis | 0/145 (0%) | 2/299 (0.7%) | ||
Pneumonia | 2/145 (1.4%) | 1/299 (0.3%) | ||
Bacteraemia | 0/145 (0%) | 1/299 (0.3%) | ||
COVID-19 | 0/145 (0%) | 1/299 (0.3%) | ||
Cellulitis | 0/145 (0%) | 1/299 (0.3%) | ||
Diabetic gangrene | 0/145 (0%) | 1/299 (0.3%) | ||
Herpes zoster | 0/145 (0%) | 1/299 (0.3%) | ||
Metapneumovirus infection | 0/145 (0%) | 1/299 (0.3%) | ||
Otitis media | 0/145 (0%) | 1/299 (0.3%) | ||
Urinary tract infection | 0/145 (0%) | 1/299 (0.3%) | ||
Urosepsis | 0/145 (0%) | 1/299 (0.3%) | ||
Appendicitis | 1/145 (0.7%) | 0/299 (0%) | ||
COVID-19 pneumonia | 1/145 (0.7%) | 0/299 (0%) | ||
Diabetic foot infection | 1/145 (0.7%) | 0/299 (0%) | ||
Gastroenteritis | 1/145 (0.7%) | 0/299 (0%) | ||
Pneumonia pneumococcal | 1/145 (0.7%) | 0/299 (0%) | ||
Injury, poisoning and procedural complications | ||||
Fall | 0/145 (0%) | 3/299 (1%) | ||
Accidental overdose | 0/145 (0%) | 1/299 (0.3%) | ||
Craniocerebral injury | 0/145 (0%) | 1/299 (0.3%) | ||
Joint injury | 0/145 (0%) | 1/299 (0.3%) | ||
Patella fracture | 0/145 (0%) | 1/299 (0.3%) | ||
Animal bite | 1/145 (0.7%) | 0/299 (0%) | ||
Road traffic accident | 1/145 (0.7%) | 0/299 (0%) | ||
Upper limb fracture | 1/145 (0.7%) | 0/299 (0%) | ||
Investigations | ||||
Blood glucose decreased | 0/145 (0%) | 1/299 (0.3%) | ||
Blood glucose increased | 0/145 (0%) | 1/299 (0.3%) | ||
Glomerular filtration rate decreased | 0/145 (0%) | 1/299 (0.3%) | ||
Metabolism and nutrition disorders | ||||
Diabetic ketoacidosis | 0/145 (0%) | 2/299 (0.7%) | ||
Dehydration | 1/145 (0.7%) | 1/299 (0.3%) | ||
Hyperglycaemia | 0/145 (0%) | 1/299 (0.3%) | ||
Hyperkalaemia | 0/145 (0%) | 1/299 (0.3%) | ||
Hypoglycaemia | 0/145 (0%) | 1/299 (0.3%) | ||
Hypokalaemia | 1/145 (0.7%) | 0/299 (0%) | ||
Musculoskeletal and connective tissue disorders | ||||
Intervertebral disc degeneration | 0/145 (0%) | 1/299 (0.3%) | ||
Tendonitis | 0/145 (0%) | 1/299 (0.3%) | ||
Osteoarthritis | 1/145 (0.7%) | 0/299 (0%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Squamous cell carcinoma of skin | 0/145 (0%) | 1/299 (0.3%) | ||
Plasmacytoma | 1/145 (0.7%) | 0/299 (0%) | ||
Nervous system disorders | ||||
Cervical radiculopathy | 0/145 (0%) | 1/299 (0.3%) | ||
Headache | 0/145 (0%) | 1/299 (0.3%) | ||
Migraine | 0/145 (0%) | 1/299 (0.3%) | ||
Transient ischaemic attack | 0/145 (0%) | 1/299 (0.3%) | ||
Vertebral artery occlusion | 0/145 (0%) | 1/299 (0.3%) | ||
Cerebrovascular accident | 1/145 (0.7%) | 0/299 (0%) | ||
Lumbar radiculopathy | 1/145 (0.7%) | 0/299 (0%) | ||
Presyncope | 1/145 (0.7%) | 0/299 (0%) | ||
Psychiatric disorders | ||||
Suicide attempt | 0/145 (0%) | 1/299 (0.3%) | ||
Anxiety disorder | 1/145 (0.7%) | 0/299 (0%) | ||
Major depression | 1/145 (0.7%) | 0/299 (0%) | ||
Renal and urinary disorders | ||||
Acute kidney injury | 0/145 (0%) | 1/299 (0.3%) | ||
Ureterolithiasis | 0/145 (0%) | 1/299 (0.3%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Asthma | 1/145 (0.7%) | 3/299 (1%) | ||
Skin and subcutaneous tissue disorders | ||||
Diabetic foot | 1/145 (0.7%) | 0/299 (0%) | ||
Vascular disorders | ||||
Aortic stenosis | 0/145 (0%) | 1/299 (0.3%) | ||
Hypertension | 0/145 (0%) | 1/299 (0.3%) | ||
Hypotension | 0/145 (0%) | 1/299 (0.3%) | ||
Peripheral arterial occlusive disease | 0/145 (0%) | 1/299 (0.3%) | ||
Orthostatic hypotension | 1/145 (0.7%) | 0/299 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Placebo | Relamorelin 10 μg | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 37/145 (25.5%) | 82/299 (27.4%) | ||
Gastrointestinal disorders | ||||
Diarrhoea | 14/145 (9.7%) | 21/299 (7%) | ||
Infections and infestations | ||||
Urinary tract infection | 9/145 (6.2%) | 28/299 (9.4%) | ||
Metabolism and nutrition disorders | ||||
Hyperglycaemia | 8/145 (5.5%) | 15/299 (5%) | ||
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 11/145 (7.6%) | 18/299 (6%) | ||
Nervous system disorders | ||||
Headache | 7/145 (4.8%) | 15/299 (5%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Therapeutic Area, Head |
---|---|
Organization | Allergan |
Phone | 714-246-4500 |
clinicaltrials@allergan.com |
- RLM-MD-04
- 2017-002144-33